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Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A03490 Active (1S,2R)-Eliglustat Diastereomer (25 mg) (N- Pharmace F204G0 1092472- N/A $2,700.00 IN Chemical 25 EACH 2934990005 VIAL No No
[(1S,2R)-2-(2,3-Dihydro-1,4-benzodioxin-6-yl)-2- utical 65-5 Synthesis
hydroxy-1-(1-pyrrolidinylmethyl)ethyl]octanamide) Analytical
Impurity
1A03030 Active (3R,4R)-Paroxol (25 mg) (((3R,4R)-4-(4- Pharmace F193F0 100332-12- N/A $1,400.00 IN Chemical 25 EACH 2933399095 VIAL No No
fluorophenyl)-1-methylpiperidin-3-yl)methanol) utical 5 Synthesis
Analytical
Impurity
1A03020 Active (3S,4S)-Paroxol (25 mg) (((3S, 4S)-4-(4- Pharmace F193E0 100332-20- N/A $1,400.00 IN Chemical 25 EACH 2933399095 VIAL No No
fluorophenyl)-1-methylpiperidin-3-yl)methanol) utical 5 Synthesis
Analytical
Impurity
1A02040 Active (4-Methylbenzoyl)trifluoroacetone (25 mg) (1,1,1- Pharmace Celecoxib F187K0 910303-54- N/A $450.00 IN Chemical 25 EACH 2914790000 VIAL No No
Trifluoro-4-hydroxy-4-(4-methylphenyl)-3-buten-2- utical 7 Synthesis
one) Analytical
Impurity
1A04550 Active (7,7'-(Butane-1,4-diylbis(oxy))bis(quinolin-2(1H)- Pharmace Coming 2116542- N/A Coming 25 EACH 2933790002 No No
one)) utical Soon 19-7 Soon
Analytical
Impurity
1A01970 Active (R)-Amlodipine (25 mg) (3-ethyl 5-methyl (R)-2- Pharmace Amlodipine F18320 103129-81- N/A $600.00 IN Chemical 25 EACH 2933399095 VIAL No No
((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6- utical 3 Synthesis
methyl-1,4-dihydropyridine-3,5-dicarboxylate) Analytical
Impurity
1A00550 Active (R)-Clopidogrel Carboxylic Acid (10 mg) ((R)-2-(2- Pharmace Clopidogrel F167S0 324757-50- N/A $800.00 CN Chemical 10 EACH 2934990005 VIAL No No
chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin- utical Bisulfate 8 Synthesis
5(4H)-yl)acetic acid) Analytical
Impurity
1A02700 Active (R)-Laudanosine (25 mg) ((R)-1-(3,4- Pharmace Cisatracuri F18910 85-63-2 N/A $800.00 IN Chemical 25 EACH 2933497050 VIAL No No
Dimethoxybenzyl)-6,7-dimethoxy-2-methyl- utical um Synthesis
1,2,3,4-tetrahydroisoquinoline) Analytical Besylate
Impurity
1A02860 Active (R)-N-Methyllaudanosine Iodide (25 mg) ((R)-1- Pharmace Cisatracuri F190A0 41431-32-7 N/A $750.00 CN Chemical 25 EACH 2933497050 VIAL No No
(3,4-dimethoxybenzyl)-6,7-dimethoxy-2,2- utical um Synthesis
dimethyl-1,2,3,4-tetrahydroisoquinolin-2-ium, Analytical Besylate
iodide) Impurity

Page 1
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A03220 Active (S)-2-Amino-4-morpholinobutanoic acid Pharmace F196D0 N/A N/A $770.00 CN Chemical 25 EACH 2934990005 VIAL No No
hydrochloride (25 mg) ((S)-2-amino-4- utical Synthesis
morpholinobutanoic acid, hydrochloride) Analytical
Impurity
1A01540 Active (S)-Glycidyl Phthalimide (25 mg) ((S)-2-(oxiran-2- Pharmace Rivaroxaba F17760 161596-47- N/A $770.00 CN Chemical 25 EACH 2925190100 VIAL No No
ylmethyl)isoindoline-1,3-dione) utical n 0 Synthesis
Analytical
Impurity
1A02630 Active (S)-Sitagliptin Phosphate (25 mg) ((S)-3-amino-1- Pharmace Sitagliptin F18820 823817-58- N/A $1,000.00 IN Chemical 25 EACH 2933599550 VIAL No No
(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3- utical 9 Synthesis
a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan- Analytical
1-one phosphate) Impurity
1A01030 Active 1,2-Dihydro Fluticasone Propionate (25 mg) Pharmace Fluticasone F174T0 105613-90- N/A $1,100.00 CN Chemical 25 EACH 2930909265 VIAL No No
utical Propionate 9 Synthesis
Analytical
Impurity
1A04670 Active 1,3-Dimethyl-6-nitroindazole (25 mg) (1,3- Pharmace F207V0 1354224- N/A $750.00 CN Chemical 25 EACH 2933998350 VIAL No No
dimethyl-6-nitro-1H-indazole) utical 47-7 Synthesis
Analytical
Impurity
1A02590 Active 1,4-Bis(4-(2,3-dichlorophenyl)piperazin-1- Pharmace Aripiprazol F18710 N/A N/A $880.00 CN Chemical 25 EACH 2933599550 VIAL No No
yl)butane dihydrochloride (25 mg) (1,4-bis(4-(2,3- utical e Synthesis
dichlorophenyl)piperazin-1-yl)butane, Analytical
hydrochloride) Impurity
1A04080 Active 1-(2-Methoxyphenyl)-4-nitrosopiperazine Solution Pharmace F205S0 2219339- N/A $375.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
(1 mL (1 mg/mL)) (1-(2-Methoxyphenyl)-4- utical 64-5 Synthesis
nitrosopiperazine) Analytical
Impurity
1A04420 Active 1-Benzhydryl-4-nitrosopiperazine (10 mg) (1- Pharmace F20580 1698-25-5 N/A $490.00 IN Chemical 10 EACH 2933599550 VIAL No No
Benzhydryl-4-nitrosopiperazine) utical Synthesis
Analytical
Impurity
1A04130 Active 1-Benzhydryl-4-nitrosopiperazine Solution (1 mL Pharmace F205U0 1698-25-5 N/A $395.00 IN Chemical UN1230 1 EACH 2933599550 AMPULE No No
(1 mg/mL)) (1-benzhydryl-4-nitrosopiperazine) utical Synthesis
Analytical
Impurity

Page 2
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A04190 Active 1-Cyclopentyl-4-nitrosopiperazine (CPNP) Pharmace F20390 61379-66-6 N/A $440.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
Solution (1 mL (1 mg/mL)) (1-Cyclopentyl-4- utical Synthesis
nitrosopiperazine) Analytical
Impurity
1A04540 Active 1-Methoxy Empagliflozin (25 mg) Pharmace F20680 1279691- N/A $1,500.00 CN Chemical 25 EACH 2932190002 VIAL No No
((2S,3R,4S,5S,6R)-2-(4-chloro-3-(4-(((S)- utical 36-9 Synthesis
tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-6- Analytical
(hydroxymethyl)-2-methoxytetrahydro-2H-pyran- Impurity
3,4,5-triol)
1A04020 Active 1-Methyl-4-nitrosopiperazine (MNP) Solution (1 Pharmace F20370 16339-07-4 N/A $410.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
mL (1 mg/mL)) (1-Methyl-4-nitrosopiperazine) utical Synthesis
Analytical
Impurity
1A02920 Active 1-Oxo Ivabradine Hydrochloride (25 mg) ((S)-3-(3- Pharmace Ivabradine F190C0 1616710- N/A $2,000.00 CN Chemical 25 EACH 2933790002 VIAL No No
(((3,4-dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7- utical Hydrochori 50-9 Synthesis
yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy- Analytical de
4,5-dihydro-1H-benzo[d]azepine-1,2(3H)-dione, Impurity
hydrochloride)
1A01040 Active 11-Ketofluticasone Propionate (25 mg) Pharmace Fluticasone F174U0 1219174- N/A $900.00 CN Chemical 25 EACH 2930909265 VIAL No No
((6S,8S,9R,10S,13S,14S,16R,17R)-6,9-Difluoro- utical Propionate 94-3 Synthesis
17-(((fluoromethyl)thio)carbonyl)-10,13,16- Analytical
trimethyl-3,11-dioxo- Impurity
6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-
cyclopenta[a]phenanthren-17-yl propionate)
1A01230 Active 16Alpha-Hydroxy Prednisolone-14-ene (25 mg) Pharmace Budesonid F174W0 131918-73- N/A $900.00 CN Chemical 25 EACH 2914409000 VIAL No No
((8R,9S,10R,11S,13S,16R,17S)-11,16,17- utical e 5 Synthesis
trihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl- Analytical
6,7,8,9,10,11,12,13,16,17-decahydro-3H- Impurity
cyclopenta[a]phenanthren-3-one)
1A01220 Active 16Alpha-Hydroxy Prednisolone-14-ene Acetate Pharmace Budesonid F175M0 131918-72- N/A $1,200.00 CN Chemical 25 EACH 2918992090 VIAL No No
(25 mg) (2-Oxo-2- utical e 4 Synthesis
((8R,9S,10R,11S,13S,16R,17S)-11,16,17- Analytical
trihydroxy-10,13-dimethyl-3-oxo- Impurity
6,7,8,9,10,11,12,13,16,17-decahydro-3H-
cyclopenta[a]phenanthren-17-yl)ethyl acetate)
1A01260 Active 16Alpha-Hydroxy Prednisolone-9(11)-ene (25 mg) Pharmace Budesonid F175D0 39672-76-9 N/A $770.00 CN Chemical 25 EACH 2914409000 VIAL No No

Page 3
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
((8S,10S,13S,14S,16R,17S)-16,17-dihydroxy-17- utical e Synthesis
(2-hydroxyacetyl)-10,13-dimethyl- Analytical
6,7,8,10,12,13,14,15,16,17-decahydro- Impurity
3Hcyclopenta[a]phenanthren-3-one)
1A01270 Active 16Alpha-Hydroxy Prednisolone-9(11)-ene Acetate Pharmace Budesonid F174X0 77017-20-0 N/A $1,000.00 CN Chemical 25 EACH 2918992090 VIAL No No
(25 mg) (2-((8S,10S,13S,14S,16R,17S)-16,17- utical e Synthesis
dihydroxy-10,13-dimethyl-3-oxo- Analytical
6,7,8,10,12,13,14,15,16,17-decahydro-3H- Impurity
cyclopenta[a]phenanthren-17-yl)-2-oxoethyl
acetate)
1A01280 Active 16Alpha-Hydroxy Prednisolone-9(11)-ene Pharmace Budesonid F174Y0 95943-95-6 N/A $1,000.00 CN Chemical 25 EACH 2918992090 VIAL No No
Diacetate (25 mg) (2-((8S,10S,13S,14S,16R,17S)- utical e Synthesis
16-acetoxy-17-hydroxy-10,13-dimethyl-3-oxo- Analytical
6,7,8,10,12,13,14,15,16,17-decahydro-3H- Impurity
cyclopenta[a]phenanthren-17-yl)-2-oxoethyl
acetate)
1A01250 Active 16Alpha-Hydroxy-11-keto Prednisolone (25 mg) Pharmace Budesonid F175P0 3754-05-0 N/A $600.00 CN Chemical 25 EACH 2914409000 VIAL No No
(8S,9S,10R,13S,14S,16R,17S)-16,17-dihydroxy- utical e Synthesis
17-(2-hydroxyacetyl)-10,13-dimethyl- Analytical
7,8,9,10,12,13,14,15,16,17-decahydro-3H- Impurity
cyclopenta[a]phenanthrene-3,11(6H)-dione)
1A01240 Active 16Alpha-Hydroxy-11-keto Prednisolone Acetate Pharmace Budesonid F175N0 3949-79-9 N/A $800.00 CN Chemical 25 EACH 2918992090 VIAL No No
(25 mg) (2-((8S,9S,10R,13S,14S,16R,17S)-16,17- utical e Synthesis
dihydroxy-10,13-dimethyl-3,11-dioxo- Analytical
6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H- Impurity
cyclopenta[a]phenanthren-17-yl)-2-oxoethyl
acetate)
1A00880 Active 16alpha-Hydroxyprednisolone (25 mg) Pharmace Budesonid F173S0 13951-70-7 N/A $450.00 CN Chemical 25 EACH 2914409000 VIAL No No
((8S,9S,10R,11S,13S,14S,16R,17S)-11,16,17- utical e Synthesis
trihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl- Analytical
6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H- Impurity
cyclopenta[a]phenanthren-3-one)
1A00470 Active 17-Oxo Dexamethasone (10 mg) Pharmace Dexametha F16870 1880-61-1 N/A $400.00 CN Chemical 10 EACH 2934100000 VIAL No No
((8S,9R,10S,11S,13S,14S,16R)-9-fluoro-11- utical sone Synthesis
hydroxy-10,13,16-trimethyl- Analytical
7,8,9,10,11,12,13,14,15,16-decahydro-3H- Impurity

Page 4
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
cyclopenta[a]phenanthrene-3,17(6H)-dione)
1A02010 Active 17alpha-Hydroxy13(17)a-homoprednisolone (25 Pharmace Budesonid F18300 N/A N/A $800.00 CN Chemical 25 EACH 2937290000 VIAL No No
mg) ((2R,3R,4aS,4bS,10aR,10bS,11S,12aS)- utical e Synthesis
2,3,11-trihydroxy-2-(hydroxymethyl)-10a,12a- Analytical
dimethyl-3,4,4a,5,6,10a,10b,11,12,12a- Impurity
decahydrochrysene-1,8(2H,4bH)-dione)
1A01340 Active 2,3-Dimethyl-2,3-butanediamine Dihydrochloride Pharmace Clavulanat F17540 75804-28-3 N/A $770.00 CN Chemical 25 EACH 2921290055 VIAL No No
(25 mg) (2,3-dimethylbutane-2,3-diamine, utical e Synthesis
hydrochloride) Analytical Potassium
Impurity
1A02780 Active 2,4,5-Trimethylketoprofen (25 mg) (COLD Pharmace Ketoprofen F194Y0 1797984- N/A $850.00 IN Chemical 25 EACH 2918300000 VIAL No No
SHIPMENT REQUIRED) ((2RS)-2-[3-(2,4,5- utical 80-5 Synthesis
Trimethylbenzoyl)phenyl]propanoic Acid) Analytical
Impurity
1A03830 Active 2,4-Dichloro Vilanterol Trifenatate Isomer (25 mg) Pharmace F20600 N/A N/A $1,750.00 CN Chemical 25 EACH 2922504500 VIAL No No
((R)-4-(2-((6-(2-((2,4- utical Synthesis
dichlorobenzyl)oxy)ethoxy)hexyl)amino)-1- Analytical
hydroxyethyl)-2-(hydroxymethyl)phenol, Impurity
triphenylacetate)
1A02830 Active 2,4-Difluoro Sitagliptin (25 mg) ((3R)-3-Amino-4- Pharmace Sitagliptin F188Y0 945261-48- N/A $900.00 IN Chemical 25 EACH 2933599550 VIAL No No
(2,4-difluorophenyl)-1-[3-(trifluoromethyl)-5,6- utical 3 Synthesis
dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]butan- Analytical
1-one) Impurity
1A03840 Active 2,5-Dichloro Vilanterol Trifenatate Isomer (25 mg) Pharmace F20430 N/A N/A $1,500.00 CN Chemical 25 EACH 2922504500 VIAL No No
((R)-4-(2-((6-(2-((2,5- utical Synthesis
dichlorobenzyl)oxy)ethoxy)hexyl)amino)-1- Analytical
hydroxyethyl)-2-(hydroxymethyl)phenol, 2,2,2- Impurity
triphenylacetate)
1A02820 Active 2,5-Difluoro Sitagliptin (25 mg) ((3R)-3-Amino-4- Pharmace Sitagliptin F188X0 486460-31- N/A $900.00 IN Chemical 25 EACH 2933599550 VIAL No No
(2,5-difluorophenyl)-1-[3-(trifluoromethyl)-5,6- utical 5 Synthesis
dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]butan- Analytical
1-one) Impurity
1A02750 Active 2-(3-Carboxyphenyl)propionitrile (25 mg) (2-(3- Pharmace Ketoprofen F18920 5537-71-3 N/A $600.00 IN Chemical 25 EACH 2926900005 VIAL No No
Carboxyphenyl)propionitrile) utical Synthesis
Analytical

Page 5
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
Impurity
1A04440 Active 2-(4-Nitrosopiperazin-1-yl)pyrimidine (10 mg) (2- Pharmace F206B0 872826-80- N/A $495.00 IN Chemical 10 EACH 2933599550 VIAL No No
(4-nitrosopiperazin-1-yl)pyrimidine) utical 7 Synthesis
Analytical
Impurity
1A04170 Active 2-(4-Nitrosopiperazin-1-yl)pyrimidine Solution (1 Pharmace F209K0 872826-80- N/A $395.00 IN Chemical UN1230 1 EACH 2933599550 AMPULE No No
mL (1 mg/mL)) (2-(4-nitrosopiperazin-1- utical 7 Synthesis
yl)pyrimidine) Analytical
Impurity
1A04850 Active 2-(Chloromethyl)-4-methylquinazoline Pharmace Coming 109113-72- N/A Coming UN3077 EACH 2933599550 No No
utical Soon 6 Soon
Analytical
Impurity
1A02450 Active 2-Dechloro Aripiprazole (25 mg) (7-(4-(4-(3- Pharmace Aripiprazol F184X0 203395-82- N/A $500.00 CN Chemical 25 EACH 2933790002 VIAL No No
chlorophenyl)piperazin-1-yl)butoxy)-3,4- utical e 8 Synthesis
dihydroquinolin-2(1H)-one) Analytical
Impurity
1A02440 Active 2-Monobromo Aripiprazole Hydrochloride (25 mg) Pharmace Aripiprazol F18680 2748462- N/A $1,400.00 CN Chemical 25 EACH 2933790002 VIAL No No
(7-(4-(4-(2-bromophenyl)piperazin-1-yl)butoxy)- utical e 55-5 Synthesis
3,4-dihydroquinolin-2(1H)-one, hydrochloride) Analytical
Impurity
1A00560 Active 2-Oxo Clopidogrel (Mixture of Diastereomers) (10 Pharmace Clopidogrel F168C0 109904-27- N/A $450.00 CN Chemical 10 EACH 2934990005 VIAL No No
mg) (methyl 2-(2-chlorophenyl)-2-(2-oxo-2,6,7,7a- utical Bisulfate 0 Synthesis
tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate) Analytical
Impurity
1A00570 Active 2-Oxo R-Clopidogrel (10 mg) (methyl (2R)-2-(2- Pharmace Clopidogrel F167R0 1360923- N/A $500.00 CN Chemical 10 EACH 2934990005 VIAL No No
chlorophenyl)-2-(2-oxo-2,6,7,7a- utical Bisulfate 54-1 Synthesis
tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate) Analytical
Impurity
1A03210 Active 2-{4-[(methylamino)methyl]thiazol-2-yl}propan-2-ol Pharmace F195X0 N/A N/A $880.00 CN Chemical 25 EACH 2934100000 VIAL No No
hydrochloride (25 mg) (2-(4- utical Synthesis
((methylamino)methyl)thiazol-2-yl)propan-2-ol, Analytical
hydrochloride) Impurity
1A02730 Active 21-Desacetyl Deflazacort (25 mg) Pharmace Deflazacort F193D0 13649-57-5 N/A $1,000.00 25 EACH 2934990005 No No
((11Beta,16Beta)-11,21-Dihydroxy-2'-methyl-5'H- utical

Page 6
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
pregna-1,4-dieno[17,16-d]oxazole-3,20-dione) Analytical
Impurity
1A00210 Active 3'-(N,N-Didemethyl)-3'-N-formylazithromycin (25 Pharmace Azithromyci R184E0 F160F0 765927-71- N/A $2,364.00 CN Chemical 25 EACH 2934990005 VIAL No No
mg) utical n 7 Synthesis
Analytical
Impurity
1A00070 Active 3'-(N,N-Didemethyl)azithromycin; Pharmace Azithromyci R17641 R17640 612069-27- N/A $882.00 CN Chemical 25 EACH 2934990005 VIAL No No
(Aminoazithromycin) (25 mg) utical n 9 Synthesis
Analytical
Impurity
1A00080 Active 3'-De(dimethylamino)-3'-oxoazithromycin (25 mg) Pharmace Azithromyci R20200 F15990 612069-25- N/A $3,100.00 IN Chemical 25 EACH 2934990005 VIAL No No
utical n 7 Synthesis
Analytical
Impurity
1A00840 Active 3'-Demethyl-3'-N-[(4- Pharmace Azithromyci F173Q0 612069-31- N/A $800.00 CN Chemical 25 EACH 2935909550 VIAL No No
methylphenyl)sulfonyl]azithromycin (25 mg) utical n 5 Synthesis
Analytical
Impurity
1A04490 Active 3-Acetamidophthalic acid (25 mg) (3- Pharmace F205K0 15371-06-9 N/A $750.00 CN Chemical 25 EACH 2924296000 VIAL No No
acetamidophthalic acid) utical Synthesis
Analytical
Impurity
1A04680 Active 3-Amino-4-tolylsulfonamide (25 mg) (3-amino-4- Pharmace F207W0 6274-28-8 N/A $750.00 CN Chemical 25 EACH 2935909550 VIAL No No
methylbenzenesulfonamide) utical Synthesis
Analytical
Impurity
1A02760 Active 3-Carboxyphenylacetonitrile (25 mg) (3- Pharmace Ketoprofen F194L0 5689-33-8 N/A $600.00 IN Chemical 25 EACH 2926900005 VIAL No No
(Cyanomethyl)benzoic acid) utical Synthesis
Analytical
Impurity
1A03300 Active 3-Chloropropiophenone (25 mg) (1-Phenyl-3- Pharmace 936-59-4 N/A $290.00 25 EACH 2914790000 No No
chloro-1-propanone; 1-(3-Chlorophenyl)propan-1- utical
one) Analytical
Impurity
1A02570 Active 3-Dechloro Aripiprazole (25 mg) (7-(4-(4-(2- Pharmace Aripiprazol F186V0 203395-81- N/A $1,200.00 CN Chemical 25 EACH 2933790002 VIAL No No
chlorophenyl)piperazin-1-yl)butoxy)-3,4- utical e 7 Synthesis

Page 7
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
dihydroquinolin-2(1H)-one) Analytical
Impurity
1A03530 Active 3-Deoxy 3-Chloroabiraterone (25 mg) (3Beta- Pharmace F202H0 N/A N/A $750.00 IN Chemical 25 EACH 2933399095 VIAL No No
Chloro-17-(pyridin-3-yl)androsta-5,16-diene) utical (31- Synthesis
Analytical MAY-
Impurity 2024)
1A02930 Active 3-Desmethyl Ivabradine Hydrochloride (25 mg) Pharmace Ivabradine F190B0 N/A N/A $2,850.00 CN Chemical 25 EACH 2933790002 VIAL No No
(1,3,4,5-tetrahydro-3-[3-[[[(7S)-3-hydroxy-4- utical Hydrochori Synthesis
methoxybicyclo[4.2.0]octa-1,3,5-trien-7- Analytical de
yl]methyl]methylamino]propyl]-7,8-dimethoxy-2H- Impurity
3-benzazepin-2-one, hydrochloride)
1A01650 Active 3-Hydroxy Desloratadine (25 mg) (8-chloro-11- Pharmace Desloratadi F177D0 119410-08- N/A $1,200.00 CN Chemical 25 EACH 2933399095 VIAL No No
(piperidin-4-ylidene)-6,11-dihydro-5H- utical ne 1 Synthesis
benzo[5,6]cyclohepta[1,2-b]pyridin-3-ol) Analytical
Impurity
1A04580 Active 3-Hydroxyphenyl Cinnamamide Pharmace Coming 616227-75- N/A Coming EACH 2924296000 No No
utical Soon 9 Soon
Analytical
Impurity
1A04330 Active 3-Methyl Formoterol (50 mg) (N-(2-hydroxy-5-(1- Pharmace F205M0 1616967- N/A $2,000.00 IN Chemical 50 EACH 2924296000 VIAL No No
hydroxy-2-((1-(4-methoxy-3-methylphenyl)propan- utical 26-0 Synthesis
2-yl)amino)ethyl)phenyl)formamide) Analytical
Impurity
1A04880 Active 3-Methyl-7-(2-butyn-1-yl)-8-bromoxanthine Pharmace Coming 666816-98- N/A Coming EACH 2933599550 No No
utical Soon 4 Soon
Analytical
Impurity
1A02030 Active 4'-Hydroxycelecoxib (25 mg) (4-(5-(4- Pharmace Celecoxib F184M0 170571-00- N/A $450.00 CN Chemical 25 EACH 2935909550 VIAL No No
(hydroxymethyl)phenyl)-3-(trifluoromethyl)-1H- utical 3 Synthesis
pyrazol-1-yl)benzenesulfonamide) Analytical
Impurity
1A04370 Active 4-(N-Methyl-N-nitrosamino)-1-(pyridin-3-yl)-1- Pharmace F206G0 64091-91-4 N/A $485.00 IN Chemical 10 EACH 2933399095 VIAL No No
butanone (NNK) (10 mg) (N-methyl-N-(4-oxo-4- utical Synthesis
(pyridin-3-yl)butyl)nitrous amide) Analytical
Impurity

Page 8
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A02950 Active 4-Desmethyl Ivabradine Hydrochloride (25 mg) Pharmace Ivabradine F193B0 N/A N/A $1,650.00 CN Chemical 25 EACH 2933790002 VIAL No No
((S)-3-(3-(((4-hydroxy-3- utical Hydrochori Synthesis
methoxybicyclo[4.2.0]octa-1(6),2,4-trien-7- Analytical de
yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy- Impurity
1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one,
hydrochloride)
1A00580 Active 4-Fluoro Risperidone (COLD SHIPMENT Pharmace Risperidon F17030 N/A N/A $450.00 IN Chemical 10 EACH 2934990005 VIAL No No
REQUIRED) (10 mg) (3-(2-(4-(4- utical e Synthesis
fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-2- Analytical
methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2- Impurity
a]pyrimidin-4-one)
1A02160 Active 4-Hydroxy Duloxetine Acetate (25 mg) ((S)-4-(3- Pharmace Duloxetine F18340 2705426- N/A $1,400.00 CN Chemical 25 EACH 2934990005 VIAL No No
(methylamino)-1-(thiophen-2- utical 23-7 Synthesis
yl)propoxy)naphthalen-1-ol, acetate) Analytical
Impurity
1A00900 Active 4-Methylacetophenone (1-(4-Methylphenyl)-1- Pharmace Celecoxib F17310 122-00-9 N/A $450.00 IN Chemical 25 EACH 2914399000 AMPULE No No
ethanone (4'-Methylacetophenone)) utical Synthesis
Analytical
Impurity
1A04140 Active 4-Nitroso-1-(4-fluorobenzoyl)piperazine Solution Pharmace F205V0 2892260- N/A $390.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
(1 mL (1 mg/mL)) ((4-fluorophenyl)(4- utical 28-3 Synthesis
nitrosopiperazin-1-yl)methanone) Analytical
Impurity
1A04410 Active 4-Nitrosopiperazine-1-ethanol (10 mg) (2-(4- Pharmace F20570 48121-20-6 N/A $495.00 IN Chemical 10 EACH 2933599550 VIAL No No
Nitrosopiperazin-1-yl)ethan-1-ol) utical Synthesis
Analytical
Impurity
1A04100 Active 4-Nitrosopiperazine-1-ethanol Solution (1 mL (1 Pharmace F205T0 48121-20-6 N/A $395.00 IN Chemical UN1230 1 EACH 2929909000 AMPULE No No
mg/mL)) (2-(4-Nitrosopiperazin-1-yl)ethan-1-ol) utical Synthesis
Analytical
Impurity
1A04820 Active 4-Phenylbutyl(benzyl)amine hydrochloride (25 mg) Pharmace F208B0 144391-74- N/A $750.00 CN Chemical 25 EACH 2921490002 VIAL No No
(N-benzyl-4-phenylbutan-1-amine, hydrochloride) utical 2 Synthesis
Analytical
Impurity
1A02490 Active 5-(4-Bromobutoxy)-3,4-dihydroquinolin-2(1H)-one Pharmace Aripiprazol F185T0 63309-35-3 N/A $750.00 CN Chemical 25 EACH 2933790002 VIAL No No

Page 9
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
(25 mg) (5-(4-bromobutoxy)-3,4-dihydroquinolin- utical e Synthesis
2(1H)-one) Analytical
Impurity
1A03590 Active 5-Chloro Hydrochlorothiazide (25 mg) (5,6- Pharmace F20260 F20260 5233-42-1 N/A $800.00 CN Chemical 25 EACH 2935909550 VIAL No No
dichloro-3,4-dihydro-2H- utical (31- Synthesis
benzo[e][1,2,4]thiadiazine-7-sulfonamide 1,1- Analytical MAY-
dioxide) Impurity 2024)
1A01770 Active 5-Dimethylaminobutyryl Citalopram Oxalate (25 Pharmace Escitalopra F177L0 N/A N/A $800.00 CN Chemical 25 EACH 2932996560 VIAL No No
mg) (4-(dimethylamino)-1-(1-(3- utical m Synthesis
(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3- Analytical
dihydroisobenzofuran-5-yl)butan-1-one, oxalate) Impurity
1A00520 Active 5-Fluoro Risperidone (25 mg) (3-(2-(4-(5- Pharmace Risperidon F169E0 1199589- N/A $500.00 CN Chemical 25 EACH 2934990005 VIAL No No
fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-2- utical e 74-6 Synthesis
methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2- Analytical
a]pyrimidin-4-one) Impurity
1A03200 Active 5-Hydroxy Ivabradine (25 mg) (3-(3-((((S)-3,4- Pharmace F194N0 2253977- N/A $1,800.00 IN Chemical 25 EACH 2933790002 VIAL No No
dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7- utical 80-7 Synthesis
yl)methyl)(methyl)amino)propyl)-5-hydroxy-7,8- Analytical
dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin- Impurity
2-one)
1A03380 Active 5-Hydroxy Lenalidomide (25 mg) (3-(4-amino-5- Pharmace F199S0 1421593- N/A $2,100.00 CN Chemical 25 EACH 2933790002 VIAL No No
hydroxy-1-oxoisoindolin-2-yl)piperidine-2,6-dione) utical 78-3 Synthesis
Analytical
Impurity
1A04300 Active 6-Bromo-6-deoxy-gamma-cyclodextrin (10 mg) Pharmace F203Y0 53784-84-2 N/A $850.00 CN Chemical 10 EACH 2932999000 VIAL No No
(octakis-(6-bromo-6-deoxy)-gamma-cyclodextrin) utical Synthesis
Analytical
Impurity
1A03580 Active 6-Keto Fulvestrant (25 mg) ((7Alpha,17Beta)-7-[9- Pharmace F203M0 2858589- N/A $1,400.00 CN Chemical 25 EACH 2930902000 VIAL No No
[4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]- utical 78-1 Synthesis
3,17Beta-dihydroxyestra-1,3,5(10)-trien-6-one; Analytical
7Alpha-{9-[(4,4,5,5,5,- Impurity
Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-
triene-6-one-3,17Beta-diol)
1A01050 Active 6-Methyl-4-phenylchromanol (25 mg) (6-Methyl-4- Pharmace Tolterodine R190R0 F176R0 209747-04- N/A $900.00 IN Chemical 25 EACH 2932996560 VIAL No No
phenylchroman-2-ol) utical tartrate 6 Synthesis

Page 10
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
Analytical
Impurity
1A01060 Active 6-Methyl-4-phenylchromanone (25 mg) (6-Methyl- Pharmace Tolterodine F176S0 40546-94-9 N/A $900.00 IN Chemical 25 EACH 2932206000 VIAL No No
4-phenylchroman-2-one) utical tartrate Synthesis
Analytical
Impurity
1A04260 Active 6-O-Methylerythromycin A 9-(O-methyloxime) (25 Pharmace F20920 107216-09- N/A $850.00 CN Chemical 25 EACH 2932206000 VIAL No No
mg) utical 1 Synthesis
Analytical
Impurity
1A00110 Active 6Beta-Hydroxy Ethinyl Estradiol (25 mg) Pharmace Ethinyl R177G0 R164U0 56324-28-8 N/A $925.00 CN Chemical 25 EACH 2907290500 VIAL No No
((6R,8R,9S,13S,14S,17R)-17-ethynyl-13-methyl- utical Estradiol Synthesis
7,8,9,11,12,13,14,15,16,17-decahydro-6H- Analytical
cyclopenta[a]phenanthrene-3,6,17-triol) Impurity
1A01400 Active 6Beta-Hydroxybudesonide (25 mg) Pharmace Budesonid F179G0 88411-77-2 N/A $6,500.00 CN Chemical 25 EACH 2932999000 VIAL No No
((2R,6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-2,7- utical e Synthesis
dihydroxy-8b-(2-hydroxyacetyl)-6a,8a-dimethyl-10- Analytical
propyl-1,2,6a,6b,7,8,8a,8b,11a,12,12a,12b- Impurity
dodecahydro-4H-naphtho[2',1':4,5]indeno[1,2-
d][1,3]dioxol-4-one)
1A00100 Active 6alpha-HYDROXY ETHINYL ESTRADIOL (COLD Pharmace Ethinyl F159V0 27521-34-2 N/A $395.00 IN Chemical 25 EACH 2907290500 Cold Shipment VIAL No No
SHIPMENT REQUIRED) (25 mg) (19-Nor- utical Estradiol Synthesis Required
17alpha-pregna-1,3,5(10)-trien-20-yne- Analytical
3,6alpha,17-triol) Impurity
1A01390 Active 6alpha-Hydroxybudesonide (25 mg) Pharmace Budesonid F178L0 577777-51- N/A $3,000.00 CN Chemical 25 EACH 2932999000 VIAL No No
((2S,6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-2,7- utical e 6 Synthesis
Dihydroxy-8b-(2-hydroxyacetyl)-6a,8a-dimethyl- Analytical
10-propyl-1,2,6a,6b,7,8,8a,8b,11a,12,12a,12b- Impurity
dodecahydro-4H-naphtho[2',1':4,5]indeno[1,2-
d][1,3]dioxol-4-one)
1A04920 Active 7-Chloromethyl 17-Epidrospirenone (25 mg) Pharmace F209T0 932388-89- N/A $1,725.00 CN Chemical 25 EACH 2932206000 VIAL No No
utical 1 Synthesis
Analytical
Impurity
1A05070 Active 7-Chloromethyl Drospirenone (10 mg) Pharmace F210A0 932388-90- N/A $550.00 CN Chemical 10 EACH 2932206000 VIAL No No
utical 4 Synthesis

Page 11
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
Analytical
Impurity
1A02070 Active 7-Dehydrocholesterol (25 mg) (COLD SHIPMENT Pharmace Cholecalcif F18400 434-16-2 N/A $150.00 IN Chemical 25 EACH 2936900110 Cold Shipment VIAL No No
REQUIRED) ((3S,9S,10R,13R,14R,17R)-10,13- utical erol Synthesis Required
dimethyl-17-((R)-6-methylheptan-2-yl)- Analytical
2,3,4,9,10,11,12,13,14,15,16,17-dodecahydro-1H- Impurity
cyclopenta[a]phenanthren-3-ol)
1A02970 Active 7-Desmethyl Ivabradine (25 mg) ((S)-3-(3-(((3,4- Pharmace Ivabradine F19010 304462-60- N/A $3,000.00 CN Chemical 25 EACH 2933790002 VIAL No No
dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7- utical Hydrochori 0 Synthesis
yl)methyl)(methyl)amino)propyl)-7-hydroxy-8- Analytical de
methoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2- Impurity
one)
1A00590 Active 7-Fluoro Risperidone (COLD SHIPMENT Pharmace Risperidon F17040 N/A N/A $525.00 IN Chemical 10 EACH 2934990005 VIAL No No
REQUIRED) (10 mg) (3-(2-(4-(7- utical e Synthesis
fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-2- Analytical
methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2- Impurity
a]pyrimidin-4-one)
1A04900 Active 7-Hydroxymethyl Drospirenone (10 mg) (7Beta- Pharmace F209R0 N/A N/A $990.00 IN Chemical 10 EACH 2932206000 VIAL No No
(Hydroxymethyl)-3-oxo-15alpha,16alpha-dihydro- utical Synthesis
3'H-cyclopropa[15,16]-17alpha-pregn-4-ene- Analytical
21,17-carbolactone) Impurity
1A03510 Active 7-Keto abiraterone Acetate (25 mg) Pharmace F20750 2410075- N/A $1,500.00 IN Chemical 25 EACH 2933399095 VIAL No No
utical 48-6 Synthesis
Analytical
Impurity
1A04340 Active 8-Desmethyl Ivabradine Hydrochloride (25 mg) Pharmace Coming N/A N/A Coming CN Chemical 25 EACH 2933790002 VIAL No No
((S)-3-(3-(((3,4-dimethoxybicyclo[4.2.0]octa- utical Soon Soon Synthesis
1(6),2,4-trien-7-yl)methyl)(methyl)amino)propyl)-8- Analytical
hydroxy-7-methoxy-1,3,4,5-tetrahydro-2H- Impurity
benzo[d]azepin-2-one, hydrochloride)
1A02510 Active 8-Hydroxy-3,4-dihydroquinolin-2(1H)-one (25 mg) Pharmace Aripiprazol F184Y0 52749-50-5 N/A $880.00 CN Chemical 25 EACH 2933790002 VIAL No No
(3,4-dihydro-8-hydroxy-2(1H)-Quinolinone) utical e Synthesis
Analytical
Impurity
1A02020 Active 9-Bromo-16alpha-hydroxyprednisolone (25 mg) Pharmace Budesonid F18330 N/A N/A $1,500.00 CN Chemical 25 EACH 2937290000 VIAL No No
((8S,9R,10S,11S,13S,14S,16R,17S)-9-bromo- utical e Synthesis

Page 12
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
11,16,17-trihydroxy-17-(2-hydroxyacetyl)-10,13- Analytical
dimethyl-6,7,8,9,10,11,12,13,14,15,16,17- Impurity
dodecahydro-3H-cyclopenta[a]phenanthren-3-
one)
1A03440 Active Abiraterone Ethyl Ether (25 mg) (3- Pharmace F204P0 2484719- N/A $1,000.00 IN Chemical 25 EACH 2933399095 VIAL No No
((3S,8R,9S,10R,13S,14S)-3-ethoxy-10,13- utical 14-2 Synthesis
dimethyl-2,3,4,7,8,9,10,11,12,13,14,15- Analytical
dodecahydro-1H-cyclopenta[a]phenanthren-17- Impurity
yl)pyridine)
1A03450 Active Abiraterone Isopropyl Ether (25 mg) (3- Pharmace F200F0 2484719- N/A $800.00 CN Chemical 25 EACH 2933399095 VIAL No No
((3S,8R,9S,10R,13S,14S)-3-isopropoxy-10,13- utical 15-3 Synthesis
dimethyl-2,3,4,7,8,9,10,11,12,13,14,15- Analytical
dodecahydro-1H-cyclopenta[a]phenanthren-17- Impurity
yl)pyridine; 3beta-Isopropoxy-17-(pyridin-3-
yl)androsta-5,16-diene)
1A01070 Active Alpha-Naphthol (25 mg) (naphthalen-1-ol) Pharmace Duloxetine R188A0 F174V0 90-15-3 N/A $770.00 CN Chemical UN2811 25 EACH 2907150000 VIAL No No
utical Synthesis
Analytical
Impurity
1A01610 Active Aminophenylmorpholin-2-one (25 mg) (4-(4- Pharmace Rivaroxaba F18480 1456733- N/A $1,400.00 CN Chemical 25 EACH 2934990005 VIAL No No
aminophenyl)morpholin-2-one) utical n 00-8 Synthesis
Analytical
Impurity
1A01530 Active Aminophenylmorpholinone (25 mg) (4-(4- Pharmace Rivaroxaba F17750 438056-69- N/A $770.00 CN Chemical 25 EACH 2934990005 VIAL No No
aminophenyl)morpholin-3-one) utical n 0 Synthesis
Analytical
Impurity
1A00200 Active Amlodipine Ethyl Analog (25 mg) (diethyl 2-((2- Pharmace Amlodipine R205F0 F159B0 400024-12- N/A $495.00 CN Chemical 25 EACH 2933399095 VIAL No No
aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl- utical 6 Synthesis
1,4-dihydropyridine-3,5-dicarboxylate, maleate) Analytical
Impurity
1A00030 Active Amlodipine Methyl Analog (25 mg) (dimethyl 2-((2- Pharmace Amlodipine R202G0 F15950 400024-11- N/A $650.00 IN Chemical 25 EACH 2933399095 VIAL No No
aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl- utical 5 Synthesis
1,4-dihydropyridine-3,5-dicarboxylate, maleate) Analytical
Impurity
1A00490 Active Amoxicilloic Acid Dimers 1 and 2 (10 mg) Pharmace Amoxicillin F178E0 2088961- N/A $1,000.00 IN Chemical 10 EACH 2934100000 VIAL No No

Page 13
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
utical 38-8 Synthesis
Analytical
Impurity
1A00330 Active Amoxicilloic amoxilloic acid dimers 1, 2, 3, and 4 Pharmace Amoxicillin F20220 297175-66- N/A $2,500.00 IN Chemical 5 EACH 2934100000 VIAL No No
(5 mg) utical 7 Synthesis
Analytical
Impurity
1A03430 Active Anhydro Abiraterone (25 mg) (3- Pharmace F200E0 154229-20- N/A $2,400.00 CN Chemical 25 EACH 2933399095 VIAL No No
((8R,9S,10R,13S,14S)-10,13-dimethyl- utical 6 Synthesis
2,7,8,9,10,11,12,13,14,15-decahydro-1H- Analytical
cyclopenta[a]phenanthren-17-yl)pyridine; 17- Impurity
(Pyridin-3-yl)androsta-3,5,16-triene)
1A03650 Active Anhydroclarithromycin (25 mg) Pharmace F205X0 144604-03- N/A $700.00 IN Chemical 25 EACH 2932206000 VIAL No No
utical 5 Synthesis
Analytical
Impurity
1A04480 Active Apremilast Desphthalyl Amine (25 mg) ((S)-1-(3- Pharmace F205Y0 608141-42- N/A $750.00 CN Chemical 25 EACH 2930902000 VIAL No No
ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethan- utical 0 Synthesis
1-amine) Analytical
Impurity
1A04460 Active Apremilast Open Ring 3-acetamide (25 mg) ((S)- Pharmace F205Q0 2096492- N/A $2,600.00 IN Chemical 25 EACH 2930902000 VIAL No No
3-acetamido-2-((1-(3-ethoxy-4-methoxyphenyl)-2- utical 41-8 Synthesis
(methylsulfonyl)ethyl)carbamoyl)benzoic acid) Analytical
Impurity
1A02460 Active Aripiprazole 4,4'-dimer (25 mg) (7,7'-((((ethane- Pharmace Aripiprazol F185H0 1797986- N/A $1,700.00 CN Chemical 25 EACH 2933790002 VIAL No No
1,1-diylbis(2,3-dichloro-4,1- utical e 18-5 Synthesis
phenylene))bis(piperazine-4,1-diyl))bis(butane- Analytical
4,1-diyl))bis(oxy))bis(3,4-dihydroquinolin-2(1H)- Impurity
one)
1A02470 Active Aripiprazole Acid Analog (25 mg) (4-((2-oxo- Pharmace Aripiprazol F185R0 58899-27-7 N/A $1,200.00 CN Chemical 25 EACH 2933790002 VIAL No No
1,2,3,4-tetrahydroquinolin-7-yl)oxy)butanoic acid) utical e Synthesis
Analytical
Impurity
1A02480 Active Aripiprazole Bromobutoxyquinolinone Analog (25 Pharmace Aripiprazol F185S0 203395-59- N/A $880.00 CN Chemical 25 EACH 2933790002 VIAL No No
mg) (7-(4-bromobutoxy)quinolin-2(1H)-one) utical e 9 Synthesis
Analytical

Page 14
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
Impurity
1A02420 Active Aripiprazole Diquinolinone Butanediol (25 mg) Pharmace Aripiprazol F184U0 882880-12- N/A $770.00 CN Chemical 25 EACH 2933790002 VIAL No No
(7,7'-(butane-1,4-diylbis(oxy))bis(3,4- utical e 8 Synthesis
dihydroquinolin-2(1H)-one)) Analytical
Impurity
1A02550 Active Aripiprazole Hydroxydihydroquinolinone Analog Pharmace Aripiprazol F196Y0 22246-18-0 N/A $500.00 CN Chemical 25 EACH 2933790002 VIAL No No
(25 mg) (7-hydroxy-3,4-dihydroquinolin-2(1H)-one) utical e Synthesis
Analytical
Impurity
1A02560 Active Aripiprazole Hydroxyquinolinone Analog (25 mg) Pharmace Aripiprazol F185V0 70500-72-0 N/A $750.00 CN Chemical 25 EACH 2933790002 VIAL No No
(7-hydroxyquinolin-2(1H)-one) utical e Synthesis
Analytical
Impurity
1A02530 Active Aripiprazole Isomer (25 mg) (5-(4-(4-(2,3- Pharmace Aripiprazol F18500 203395-78- N/A $1,100.00 CN Chemical 25 EACH 2933790002 VIAL No No
dichlorophenyl)piperazin-1-yl)butoxy)-3,4- utical e 2 Synthesis
dihydroquinolin-2(1H)-one) Analytical
Impurity
1A02520 Active Aripiprazole N-oxide Isomer (25 mg) (4-(2,3- Pharmace Aripiprazol F185U0 573691-11- N/A $1,000.00 CN Chemical 25 EACH 2933790002 VIAL No No
dichlorophenyl)-1-(4-((2-oxo-1,2,3,4- utical e 9 Synthesis
tetrahydroquinolin-7-yl)oxy)butyl)piperazine 4- Analytical
oxide) Impurity
1A02540 Active Aripiprazole Spiro Analog (25 mg) (8-(2,3- Pharmace Aripiprazol F186W0 795313-24- N/A $1,100.00 CN Chemical 25 EACH 2933599550 VIAL No No
dichlorophenyl)-5,8-diazaspiro[4.5]decan-5-ium, utical e 5 Synthesis
bromide) Analytical
Impurity
1A02410 Active Aripiprazole di(quinolinonylbutyl) ether analog (25 Pharmace Aripiprazol F185W0 1424858- N/A $770.00 CN Chemical 25 EACH 2933790002 VIAL No No
mg) (7,7'-((oxybis(butane-4,1- utical e 02-5 Synthesis
diyl))bis(oxy))bis(3,4-dihydroquinolin-2(1H)-one)) Analytical
Impurity
1A00760 Active Atorvastatin 3-deoxyhept-2-enoic Acid (25 mg) Pharmace Atorvastati F178F0 1105067- N/A $1,500.00 CN Chemical 25 EACH 2933998350 VIAL No No
((S,E)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl- utical n Calcium 93-3 Synthesis
4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-5- Analytical
hydroxyhept-2-enoic acid) Impurity
1A00790 Active Atorvastatin Calcium Epoxy Pyrrolooxazin 7- Pharmace Atorvastati F198A0 N/A N/A $3,000.00 25 EACH 2934990005 No No
Hydroxy Analog (25 mg) (Calcium 4-(1b-(4- utical n Calcium

Page 15
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
fluorophenyl)-7-hydroxy-7-isopropyl-1a-phenyl-7a- Analytical
(phenylcarbamoyl)hexahydro-3H- Impurity
oxireno[2',3':3,4]pyrrolo[2,1-b][1,3]oxazin-3-yl)-3-
hydroxybutanoate)
1A00800 Active Atorvastatin Epoxy Tetrahydrofuran Analog (25 Pharmace Atorvastati F176P0 873950-19- N/A $3,000.00 IN Chemical 25 EACH 2932996560 VIAL No No
mg) (4-(4-Fluorophenyl)-2,4-dihydroxy-2-(1- utical n Calcium 7 Synthesis
methylethyl)-N,5-diphenyl-3,6- Analytical
dioxabicyclo[3.1.0]hexane-1-carboxamide) Impurity
1A00010 Active Atorvastatin Ethyl Ester (25 mg) (ethyl (3R,5R)-7- Pharmace Atorvastati F159A0 1146977- N/A $483.00 CN Chemical 25 EACH 2933998350 VIAL No No
(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- utical n Calcium 93-6 Synthesis
(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5- Analytical
dihydroxyheptanoate) Impurity
1A00020 Active Atorvastatin Methyl Ester (25 mg) (methyl Pharmace Atorvastati F16010 345891-62- N/A $474.00 CN Chemical 25 EACH 2933998350 VIAL No No
(3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3- utical n Calcium 5 Synthesis
phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5- Analytical
dihydroxyheptanoate) Impurity
1A00820 Active Atorvastatin Pyrrolidone Lactone (25 mg) (5-(4- Pharmace Atorvastati F194J0 906552-19- N/A $3,000.00 IN Chemical 25 EACH 2933790002 VIAL No No
Fluorophenyl)-1-{2-[(2R,4R)-4-hydroxy-6- utical n Calcium 0 Synthesis
oxotetrahydro-2H-pyran-2-yl]ethyl}-3-isopropyl-2- Analytical
oxo-N,4-diphenyl-2,3-dihydro-1H-pyrrole-3- Impurity
carboxamide)
1A00810 Active Atorvastatin Sodium Pyrrolidone Analog (25 mg) Pharmace Atorvastati F194H0 148217-40- N/A $3,000.00 IN Chemical 25 EACH 2933790002 VIAL No No
((3R,5R)-5-(4-Fluorophenyl)-2,3-dihydro-3,5- utical n Calcium 7 Synthesis
dihydroxy-3-(1-methylethyl)-2-oxo-4-phenyl-3- Analytical
[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Impurity
Acid Sodium Salt)
1A00830 Active Atorvastatin tert-Butyl Ester (25 mg) (tert-butyl Pharmace Atorvastati F173P0 134395-00- N/A $900.00 CN Chemical 25 EACH 2933998350 VIAL No No
(3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3- utical n Calcium 9 Synthesis
phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5- Analytical
dihydroxyheptanoate) Impurity
1A02880 Active Atracurium Iodide Quaternary Alcohol Acetate (25 Pharmace Cisatracuri F20240 N/A N/A $1,200.00 CN Chemical 25 EACH 2933497050 VIAL No No
mg) ((1R)-2-(3-((5-acetoxypentyl)oxy)-3- utical um Synthesis
oxopropyl)-1-(3,4-dimethoxybenzyl)-6,7- Analytical Besylate
dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin- Impurity
2-ium, iodide)
1A00260 Active Azacitidine Formyl Amidine Analog (25 mg) Pharmace Azacitidine R178D0 R17120 65126-88-7 N/A $4,050.00 IN Chemical 25 EACH 2932190002 International VIAL No No

Page 16
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
(INTERNATIONAL COLD CHAIN SHIPMENT utical Synthesis Cold Chain
REQUIRED) (N-(Formyl amidino)-N'-Beta-D- Analytical Shipment
ribofuranosylurea) Impurity Required
1A00270 Active Azacitidine Isomer -3 (25 mg) (1-Beta-D- Pharmace Azacitidine F165P0 2775292- N/A $4,500.00 IN Chemical 25 EACH 2932190002 VIAL No No
Ribofuranosyl-3-aminocarbonyl guanidine acetate) utical 15-2 Synthesis
Analytical
Impurity
1A00850 Active Azithromycin B (3-deoxyazithromycin) (25 mg) Pharmace Azithromyci F17910 307974-61- N/A $3,000.00 IN Chemical 25 EACH 2934990005 VIAL No No
(COLD SHIPMENT REQUIRED) utical n 4 Synthesis
Analytical
Impurity
1A00860 Active Azithromycin C (3''-O-demethylazithromycin) (25 Pharmace Azithromyci F180L0 620169-47- N/A $3,000.00 IN Chemical 25 EACH 2934990005 VIAL No No
mg) utical n 3 Synthesis
Analytical
Impurity
1A02910 Active Benzoylphenylacetonitrile (25 mg) (3- Pharmace Ketoprofen F196N0 21288-34-6 N/A $600.00 IN Chemical 25 EACH 2926900005 VIAL No No
Benzoylbenzeneacetonitrile) utical Synthesis
Analytical
Impurity
1A00540 Active Bis((R)-butyramide) (10 mg) ((R)-2-amino-N-((R)- Pharmace Levetiracet F168B0 1867585- N/A $450.00 CN Chemical 10 EACH 2924190002 VIAL No No
1-amino-1-oxobutan-2-yl)butanamide) utical am 44-1 Synthesis
Analytical
Impurity
1A01350 Active Bis(2-methylaminoethyl) Ether (25 mg) (2,2'- Pharmace Clavulanat F17550 3033-62-3 N/A $770.00 CN Chemical UN2922 25 EACH 2922199695 AMPULE No No
oxybis(N,N-dimethylethan-1-amine)) utical e Synthesis
Analytical Potassium
Impurity
1A01330 Active Bis(2-methylaminoethyl) Ether Hydrochloride (25 Pharmace Clavulanat F17530 295796-12- N/A $700.00 CN Chemical 25 EACH 2922199695 VIAL No No
mg) (2,2'-oxybis(N-methylethan-1-amine), utical e 2 Synthesis
hydrochloride) Analytical Potassium
Impurity
1A00150 Active Bis(dibenzothiazepinyl) Piperazine (25 mg) (1,4- Pharmace Quetiapine F158T0 945668-94- N/A $650.00 IN Chemical 25 EACH 2934990005 VIAL No No
Bis(dibenzo[b,f][1,4]thiazepin-11-yl)piperazine) utical fumarate 0 Synthesis
Analytical
Impurity

Page 17
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A01300 Active Bis(dimethylaminoethyl) Ether Dihydrochloride (25 Pharmace Clavulanat F17510 103526-47- N/A $700.00 CN Chemical 25 EACH 2922199695 VIAL No No
mg) (2,2'-oxybis(N,N-dimethylethan-1-amine), utical e 2 Synthesis
hydrochloride) Analytical Potassium
Impurity
1A03770 Active Bortezomib Acid Analog (25 mg) ((2S)-3-Phenyl-2- Pharmace F20530 114457-94- N/A $800.00 IN Chemical 25 EACH 2933998350 VIAL No No
[(pyrazin-2-ylcarbonyl)amino]propanoic Acid) utical 2 Synthesis
Analytical
Impurity
1A03780 Active Bortezomib Amide Analog (25 mg) (N-[(1S)-2- Pharmace F206C0 289472-80- N/A $650.00 IN Chemical 25 EACH 2933998350 VIAL No No
Amino-2-oxo-1-(phenylmethyl)ethyl]-2- utical 6 Synthesis
pyrazinecarboxamide) Analytical
Impurity
1A03400 Active Bortezomib L-phenylalanyl analog (COLD Pharmace F204N0 1194235- N/A $1,500.00 IN Chemical 25 EACH 2933998350 VIAL No No
SHIPMENT REQUIRED) (25 mg) (((R)-3-methyl- utical 41-0 Synthesis
1-((S)-3-phenyl-2-((S)-3-phenyl-2-(pyrazine-2- Analytical
carboxamido)propanamido)propanamido)butyl)bor Impurity
onic acid)
1A03480 Active Bosentan Bis4(tert-butylbenzenesulfonamide) (25 Pharmace F200P0 1218951- N/A $1,500.00 CN Chemical 25 EACH 2935909550 VIAL No No
mg) (N,N'-(5-(2-methoxyphenoxy)-[2,2'- utical 81-5 Synthesis
bipyrimidine]-4,6-diyl)bis(4-(tert- Analytical
butyl)benzenesulfonamide)) Impurity
1A04590 Active Brexpiprazole N-oxide (25 mg) (4- Pharmace F207S0 1191900- N/A $950.00 CN Chemical 25 EACH 2934990005 VIAL No No
(benzo[b]thiophen-4-yl)-1-(4-((2-oxo-1,2- utical 58-9 Synthesis
dihydroquinolin-7-yl)oxy)butyl)piperazine 1-oxide) Analytical
Impurity
1A00690 Active Bromobudesonide (25 mg) Pharmace Budesonid F177P0 313474-59- N/A $900.00 CN Chemical 25 EACH 2932999000 VIAL No No
((6aS,6bR,7S,8aS,8bS,11aR,12aS,12bS)-6b- utical e 8 Synthesis
bromo-7-hydroxy-8b-(2-hydroxyacetyl)-6a,8a- Analytical
dimethyl-10-propyl-1,2,6a,6b,7,8,8a,8b,11a,12, Impurity
12a,12b-dodecahydro-4H-
naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-4-one)
1A01370 Active Budesonide 21-butyrate (25 mg) (2- Pharmace Budesonid F17560 2408495- N/A $800.00 CN Chemical 25 EACH 2932999000 VIAL No No
((6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-7- utical e 96-3 Synthesis
hydroxy-6a,8a-dimethyl-4-oxo-10-propyl- Analytical
1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro- Impurity
8bH-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8b-

Page 18
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
yl)-2-oxoethyl butyrate)
1A00680 Active Budesonide 9(11)-ene (25 mg) Pharmace Budesonid F17270 313474-58- N/A $600.00 CN Chemical 25 EACH 2932999000 VIAL No No
((6aS,8aS,8bS,11aR,12aS,12bS)-8b-(2- utical e 7 Synthesis
hydroxyacetyl)-6a,8a-dimethyl-10-propyl- Analytical
1,2,6a,8,8a,8b,11a,12,12a,12b-decahydro-4H- Impurity
naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-4-one)
1A00510 Active Budesonide Acetaldehyde Acetal (25 mg) Pharmace Budesonid F168A0 1040085- N/A $500.00 CN Chemical 25 EACH 2932999000 VIAL No No
(16alpha,17-[(1RS)-ethylidenebis(oxy)]-11beta,21- utical e 98-0 Synthesis
dihydroxypregna-1,4-diene-3,20-dione) Analytical
Impurity
1A00500 Active Budesonide D-homo Analog (10 mg) Pharmace Budesonid R19750 F16890 1040085- N/A $500.00 CN Chemical 10 EACH 2932999000 VIAL No No
((4aR,4bS,5S,6aS,7aR,10aR,11aS,11bS)-5- utical e 99-1 Synthesis
hydroxy-7a-(hydroxymethyl)-4a,6a-dimethyl-9- Analytical
propyl-4b,6,6a,7a,10a,11,11a,11b,12,13- Impurity
decahydrochryseno[2,3-d][1,3]dioxole-
2,7(4aH,5H)-dione)
1A02000 Active Budesonide Pyruvic Acid (25 mg) (2- Pharmace Budesonid F18280 N/A N/A $1,500.00 CN Chemical 25 EACH 2932999000 VIAL No No
((6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-7- utical e Synthesis
hydroxy-6a,8a-dimethyl-4-oxo-10-propyl- Analytical
1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro- Impurity
8bH-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8b-
yl)-2-oxoacetic acid)
1A00410 Active Budesonide Sulfate Triethylamine Salt (10 mg) Pharmace Budesonid F171B0 1436872- N/A $500.00 CN Chemical 10 EACH 2932999000 VIAL No No
utical e 65-9 Synthesis
Analytical
Impurity
1A04510 Active Canagliflozin Tetraacetate (25 mg) Pharmace F20620 866607-35- N/A $950.00 CN Chemical 25 EACH 2934990005 VIAL No No
((2R,3R,4R,5S,6S)-2-(acetoxymethyl)-6-(3-((5-(4- utical 4 Synthesis
fluorophenyl)thiophen-2-yl)methyl)-4- Analytical
methylphenyl)tetrahydro-2H-pyran-3,4,5-triyl Impurity
triacetate)
1A00890 Active Carvedilol Bisalkylpyrocatechol derivative (25 mg) Pharmace Carvedilol F181P0 1346602- N/A $850.00 IN Chemical 25 EACH 2933998350 VIAL No No
(3,3'-{2,2'-[1,2-Phenylenebis(oxy)]bis(ethane-2,1- utical 98-9 Synthesis
diyl)}bis(azanediyl)bis(1-(9H-carbazol-4- Analytical
yloxy)propan-2-ol)) Impurity

Page 19
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A00910 Active Celecoxib Open Ring (25 mg) (4-((1,1,1-trifluoro- Pharmace Celecoxib F176Q0 N/A N/A $450.00 CN Chemical 25 EACH 2935909550 VIAL No No
4-hydroxy-4-(p-tolyl)but-3-en-2- utical Synthesis
ylidene)amino)benzenesulfonamide) Analytical
Impurity
1A01450 Active Chloro N-methylthiophene Carboxamide (25 mg) Pharmace Rivaroxaba F176W0 97799-98-9 N/A $880.00 CN Chemical 25 EACH 2934990005 VIAL No No
(5-chloro-N-methylthiophene-2-carboxamide) utical n Synthesis
Analytical
Impurity
1A02430 Active Chlorobutoxyquinolinone (25 mg) (7-(4- Pharmace Aripiprazol F184W0 120004-79- N/A $880.00 CN Chemical 25 EACH 2933790002 VIAL No No
chlorobutoxy)-3,4-dihydroquinolin-2(1H)-one) utical e 7 Synthesis
Analytical
Impurity
1A01560 Active Chlorothiophene Aldehyde (25 mg) (5- Pharmace Rivaroxaba F17770 7283-96-7 N/A $1,400.00 CN Chemical 25 EACH 2934990005 AMPULE No No
chlorothiophene-2-carbaldehyde) utical n Synthesis
Analytical
Impurity
1A01180 Active Chlorothiophene carboxylic acid (25 mg) (5- Pharmace Rivaroxaba F174R0 24065-33-6 N/A $770.00 CN Chemical 25 EACH 2934990005 VIAL No No
chlorothiophene-2-carboxylic acid) utical n Synthesis
Analytical
Impurity
1A03630 Active Clarithromycin E-Oxime (COLD SHIPMENT Pharmace F203L0 127253-06- N/A $650.00 IN Chemical 25 EACH 2932206000 VIAL No No
REQUIRED) (25 mg) utical 9 Synthesis
Analytical
Impurity
1A03410 Active Clarithromycin Furanyl Analog (25 mg) Pharmace F200H0 127157-35- N/A $790.00 CN Chemical 25 EACH 2932206000 VIAL No No
utical 1 Synthesis
Analytical
Impurity
1A03420 Active Clarithromycin Z-Oxime (25 mg) Pharmace F200J0 127253-05- N/A $1,250.00 CN Chemical 25 EACH 2932206000 VIAL No No
utical 8 Synthesis
Analytical
Impurity
1A00321 Active Clindamycin 3-Phosphate (COLD SHIPMENT Pharmace Clindamyci F18940 28708-34-1 N/A $790.00 IN Chemical 10 EACH 2933999552 VIAL No No
REQUIRED) (10 mg) (Methyl 7-chloro-6,7,8- utical n Synthesis
trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2- Analytical Phosphate
carboxamido]-1-thio-L-threo-alpha-D-galacto- Impurity

Page 20
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
octopyranoside 3-phosphate)
1A02100 Active Clopidogrel Acid N-Oxide (25 mg) (5-((S)- Pharmace Clopidogrel F18730 1319197- N/A $1,200.00 CN Chemical 25 EACH 2934990005 VIAL No No
carboxy(2-chlorophenyl)methyl)-4,5,6,7- utical Bisulfate 73-3 Synthesis
tetrahydrothieno[3,2-c]pyridine 5-oxide) Analytical
Impurity
1A01860 Active Clopidogrel Amide (25 mg) ((S)-2-(2- Pharmace Clopidogrel F178P0 444728-13- N/A $840.00 CN Chemical 25 EACH 2934990005 VIAL No No
chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin- utical Bisulfate 6 Synthesis
5(4H)-yl)acetamide) Analytical
Impurity
1A00420 Active Clopidogrel Diester Analog (10 mg) (R)-1-(2- Pharmace Clopidogrel F16810 1421283- N/A $450.00 CN Chemical 10 EACH 2934990005 VIAL No No
chlorophenyl)-2-methoxy-2-oxoethyl (S)-2-(2- utical Bisulfate 60-4 (free Synthesis
chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin- Analytical base)
5(4H)-yl)acetate, sulfate Impurity
1A02120 Active Clopidogrel Diester Enantiomer Sulfate (25 mg) Pharmace Clopidogrel F182B0 N/A N/A $3,500.00 CN Chemical 25 EACH 2934990005 VIAL No No
((S)-1-(2-chlorophenyl)-2-methoxy-2-oxoethyl (R)- utical Bisulfate Synthesis
2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2- Analytical
c]pyridin-5(4H)-yl)acetate, sulfate) Impurity
1A01730 Active Clopidogrel Ethyl Ester Sulfate (25 mg) (ethyl (S)- Pharmace Clopidogrel F181G0 1332612- N/A $1,100.00 CN Chemical 25 EACH 2934990005 VIAL No No
2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2- utical Bisulfate 57-3 Synthesis
c]pyridin-5(4H)-yl)acetate, sulfate) Analytical
Impurity
1A01890 Active Clopidogrel N-Oxide (25 mg) (5-((S)-1-(2- Pharmace Clopidogrel F178Q0 1319197- N/A $2,000.00 CN Chemical 25 EACH 2934990005 VIAL No No
chlorophenyl)-2-methoxy-2-oxoethyl)-4,5,6,7- utical Bisulfate 71-1 Synthesis
tetrahydrothieno[3,2-c]pyridine 5-oxide) Analytical
Impurity
1A01700 Active Clopidogrel Open Ring Hydrochloride (25 mg) Pharmace Clopidogrel F177H0 141109-19- N/A $1,000.00 CN Chemical 25 EACH 2934990005 VIAL No No
(methyl (S)-2-(2-chlorophenyl)-2-((2-(thiophen-2- utical Bisulfate 5 Synthesis
yl)ethyl)amino) acetate, hydrochloride) Analytical
Impurity
1A00430 Active Clopidogrel Open Ring Methyl Ester Hydrochloride Pharmace Clopidogrel F16840 141109-18- N/A $450.00 CN Chemical 10 EACH 2934990005 VIAL No No
(10 mg) (methyl 2-(2-chlorophenyl)-2-((2- utical Bisulfate 4 Synthesis
(thiophen-2-yl)ethyl)amino)acetate, hydrochloride) Analytical
Impurity
1A01900 Active Clopidogrel Open Ring R-enantiomer (25 mg) Pharmace Clopidogrel F179J0 1258938- N/A $2,000.00 CN Chemical 25 EACH 2934990005 VIAL No No
(methyl (R)-2-(2-chlorophenyl)-2-((2-(thiophen-2- utical Bisulfate 54-3 Synthesis

Page 21
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
yl)ethyl)amino) acetate, hydrochloride) Analytical
Impurity
1A01430 Active Clopidogrel Piperidinylidene Analog (25 mg) ((E)- Pharmace Clopidogrel F178M0 N/A N/A $4,500.00 CN Chemical 25 EACH 2933399095 VIAL No No
2-(1-(1-(2-chlorophenyl)-2-methoxy-2-oxoethyl)-4- utical Bisulfate Synthesis
((2-(3-methoxyphenyl)-2-oxoethyl)thio)piperidin-3- Analytical
ylidene)acetic acid) Impurity
1A01380 Active Clopidogrel Quaternary Salt (25 mg) (5-(1-(2- Pharmace Clopidogrel F177T0 2418591- N/A $1,200.00 CN Chemical 25 EACH 2934990005 VIAL No No
chlorophenyl)-2-methoxy-2-oxoethyl)-6,7- utical Bisulfate 12-3 Synthesis
dihydrothieno[3,2-c]pyridin-5-ium, bromide) Analytical
Impurity
1A01870 Active Clopidogrel R-Enantiomer (25 mg) ((R)-2-(2- Pharmace Clopidogrel F179H0 444728-15- N/A $800.00 CN Chemical 25 EACH 2934990005 VIAL No No
chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin- utical Bisulfate 8 Synthesis
5(4H)-yl)acetamide) Analytical
Impurity
1A02080 Active Clopidogrel Thienopyridinium Chloride (25 mg) (5- Pharmace Clopidogrel F20270 2418591- N/A $1,200.00 CN Chemical 25 EACH 2934990005 VIAL No No
(1-(2-chlorophenyl)-2-methoxy-2- utical Bisulfate 11-2 Synthesis
oxoethyl)thieno[3,2-c]pyridin-5-ium, chloride) Analytical
Impurity
1A01360 Active Clopidogrel-Beta-D-glucuronide (10 mg) Pharmace Clopidogrel F180M0 1314116- N/A $2,800.00 CN Chemical 10 EACH 2934990005 VIAL No No
((2S,3S,4S,5R,6S)-6-((S)-2-(2-chlorophenyl)-2- utical Bisulfate 53-4 Synthesis
(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetoxy)- Analytical
3,4,5-trihydroxytetrahydro-2H-pyran-2-carboxylic Impurity
acid)
1A03270 Active Cyanocobalamin 7Beta,8Beta-lactone (25 mg) Pharmace F202Y0 23208-66-4 N/A $1,200.00 IN Chemical 25 EACH 2934990005 VIAL No No
(Coalpha-[alpha-(5,6-dimethylbenzimidazolyl)]- utical Synthesis
CoBeta-cyano-8Beta-hydroxycobamic a,b,d,e,g- Analytical
pentaamide c,8-gamma-lactone) Impurity
1A03500 Active Cyclopropyldiaminopurine (25 mg) (N6- Pharmace F201E0 120503-69- N/A $475.00 IN Chemical 25 EACH 2933599550 VIAL No No
cyclopropyl-9H-purine-2,6-diamine) utical 7 Synthesis
Analytical
Impurity
1A04270 Active Cyclosporin D (25 mg) Pharmace F206Q0 63775-96-2 N/A $1,400.00 CN Chemical 25 EACH 2933790002 VIAL No No
utical Synthesis
Analytical
Impurity

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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A04280 Active Cyclosporin H (25 mg) Pharmace F20490 83602-39-5 N/A $1,700.00 CN Chemical 25 EACH 2933790002 VIAL No No
utical Synthesis
Analytical
Impurity
1A03870 Active D-Epinephrine (25 mg) ((S)-4-[1-Hydroxy-2- Pharmace F20740 150-05-0 N/A $525.00 IN Chemical 25 EACH 2922504500 VIAL No No
(methylamino)ethyl]pyrocatechol) utical Synthesis
Analytical
Impurity
1A03730 Active Dabigatran Etexilate Acid (25 mg) (3-(2-(((4-(N- Pharmace F205G0 212321-78- N/A $1,200.00 CN Chemical 25 EACH 2933399095 VIAL No No
((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino) utical 3 Synthesis
methyl)-1-methyl-N-(pyridin-2-yl)-1H- Analytical
benzo[d]imidazole-5-carboxamido)propanoic acid) Impurity
1A03740 Active Dabigatran Etexilate Isopropyl Ester (25 mg) Pharmace F20520 1610758- N/A $1,200.00 IN Chemical 25 EACH 2933399095 VIAL No No
utical 19-4 Synthesis
Analytical
Impurity
1A03750 Active Dabigatran Heptane-2-yl Analog (25 mg) (ethyl 3- Pharmace F20300 1610758- N/A $1,500.00 CN Chemical 25 EACH 2933399095 VIAL No No
(2-(((4-(N-((heptan-2- utical 21-8 Synthesis
yloxy)carbonyl)carbamimidoyl)phenyl)amino)meth Analytical
yl)-1-methyl-N-(pyridin-2-yl)-1H- Impurity
benzo[d]imidazole-5-carboxamido)propanoate)
1A00160 Active Decarboxy Levofloxacin (25 mg) (S)-9-fluoro-3- Pharmace Levofloxaci R184D0 R164A0 178964-53- N/A $550.00 IN Chemical 25 EACH 2934990005 VIAL No No
methyl-7-oxo-10-(4-methylpiperazine-1-yl)-2,3- utical n 9 Synthesis
dihydro-7H-pyrido [1,2,3-de] -1,4-benzoxazine) Analytical
Impurity
1A00990 Active Decarboxy Moxifloxacin (25 mg) (1-Cyclopropyl-6- Pharmace Moxifloxaci F178J0 1322062- N/A $500.00 IN Chemical 25 EACH 2933497050 VIAL No No
fluoro-8-methoxy-7-[(4aS,7aS)-octahydro-6H- utical n 57-6 Synthesis
pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4- Analytical
dihydroquinoline) (COLD SHIPMENT REQUIRED) Impurity
1A03640 Active Decladinosyl Clarithromycin (25 mg) (3-O-De(2,6- Pharmace F20340 118058-74- N/A $550.00 IN Chemical 25 EACH 2932206000 VIAL No No
dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo- utical 5 Synthesis
hexopyranosyl)-6-O-methylerythromycin; 3-O- Analytical
Decladinosyl-6-O-methylerythromycin A) Impurity
1A01110 Active Dehydro Desloratadine (25 mg) (8-chloro-11- Pharmace Desloratadi R19890 F173W0 117811-20- N/A $1,650.00 CN Chemical 25 EACH 2933399095 VIAL No No
(piperidin-4-ylidene)-11H- utical ne 8 Synthesis
benzo[5,6]cyclohepta[1,2-b]pyridine) Analytical

Page 23
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
Impurity
1A02980 Active Dehydro Ivabradine (25 mg) ((S)-3-(3-(((3,4- Pharmace Ivabradine F190D0 1086026- N/A $1,200.00 CN Chemical 25 EACH 2933790002 VIAL No No
dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7- utical Hydrochori 31-4 Synthesis
yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy- Analytical de
1,3-dihydro-2H-benzo[d]azepin-2-one) Impurity
1A04710 Active Deoxy Salmeterol (25 mg) (4-(1-hydroxy-2-((6-(4- Pharmace F207J0 1391054- N/A $950.00 CN Chemical 25 EACH 2922504500 VIAL No No
phenylbutoxy)hexyl)amino)ethyl)-2-methylphenol) utical 40-2 Synthesis
Analytical
Impurity
1A01210 Active Deoxyprednisolone-16-ene Acetate (25 mg) (2- Pharmace Budesonid F175T0 3044-42-6 N/A $1,200.00 CN Chemical 25 EACH 2918992090 VIAL No No
((8S,9S,10R,11S,13S,14S)-11-hydroxy-10,13- utical e Synthesis
dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15- Analytical
decahydro-3H-cyclopenta[a]phenanthren-17-yl)-2- Impurity
oxoethyl acetate)
1A01100 Active Deoxystreptamine Kanosaminide (25 mg) (6-O-(3- Pharmace Tobramycin F193J0 20744-51-8 N/A $3,000.00 IN Chemical 25 EACH 2932999000 VIAL No No
Amino-3-deoxy-alpha-D-glucopyranosyl)-2-deoxy- utical Synthesis
D-streptamine) Analytical
Impurity
1A00920 Active Desaryl Celecoxib (25 mg) (5-(p-tolyl)-3- Pharmace Celecoxib F17440 948293-46- N/A $450.00 CN Chemical 25 EACH 2933194350 VIAL No No
(trifluoromethyl)-1H-pyrazole) utical 7 Synthesis
Analytical
Impurity
1A05060 Active Desethyl Sunitinib (25 mg) ((Z)-N-(2- Pharmace F21090 356068-97- N/A $1,395.00 CN Chemical 25 EACH 2933790002 VIAL No No
(ethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3- utical 8 Synthesis
ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3- Analytical
carboxamide) Impurity
1A01080 Active Desethylamiodarone (25 mg) (2-Butyl-3- Pharmace Amiodaron F176T0 96027-74-6 N/A $650.00 IN Chemical 25 EACH 2932996560 VIAL No No
benzofuranyl-4-[2-(ethylamino)ethoxy]-3,5- utical e Synthesis
diiodophenyl Ketone Hydrochloride) Analytical
Impurity
1A03040 Active Desfluoro (3S,4R)-Paroxol (25 mg) (((3S,4R)-1- Pharmace Paroxetine F19370 176022-03- N/A $1,200.00 CN Chemical 25 EACH 2933399095 VIAL No No
methyl-4-phenylpiperidin-3-yl)methanol) utical Mesylate 0 Synthesis
Analytical
Impurity
1A01740 Active Desfluorociprofloxacin Hydrochloride (25 mg) (1- Pharmace Ciprofloxaci F181H0 2727369- N/A $770.00 CN Chemical 25 EACH 2933599550 VIAL No No

Page 24
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
cyclopropyl-4-oxo-7-(piperazin-1-yl)-1,4- utical n 47-1 Synthesis
dihydroquinoline-3-carboxylic acid, hydrochloride) Analytical
Impurity
1A01750 Active Desfluorocitalopram Oxalate (25 mg) (1-(3- Pharmace Escitalopra F17810 1093072- N/A $900.00 CN Chemical 25 EACH 2932996560 VIAL No No
(dimethylamino)propyl)-1-phenyl-1,3- utical m 86-6 Synthesis
dihydroisobenzofuran-5-carbonitrile, oxalate) Analytical
Impurity
1A04530 Active Desfuranyl Empagliflozin (25 mg) ((1S)-1,5- Pharmace F206J0 864070-37- N/A $1,350.00 IN Chemical 25 EACH 2932996560 VIAL No No
Anhydro-1-C-[4-chloro-3-[(4- utical 1 Synthesis
hydroxyphenyl)methyl]phenyl]-D-glucitol) Analytical
Impurity
1A05030 Active Desimidazoline Sunitinib Pharmace Coming 356068-86- N/A Coming EACH 2933999552 No No
utical Soon 5 Soon
Analytical
Impurity
1A00720 Active Desiodoamiodarone (25 mg) ((2-butylbenzofuran- Pharmace Amiodaron R202N0 F17280 23551-25-9 N/A $800.00 CN Chemical 25 EACH 2932996560 VIAL No No
3-yl)(4-(2- utical e Synthesis
(diethylamino)ethoxy)phenyl)methanone) Analytical
Impurity
1A02130 Active Desloratadine N-oxide (25 mg) (8-Chloro-6,11- Pharmace Desloratadi F19080 169253-26- N/A $1,200.00 IN Chemical 25 EACH 2933399095 VIAL No No
dihydro-11-(4-piperidinylidene)-5H- utical ne 3 Synthesis
benzo[5,6]cyclohepta[1,2-b]pyridine 1-Oxide) Analytical
Impurity
1A00060 Active Desmethoxy Omeprazole (25 mg) (2-(((3,5- Pharmace Omeprazol R19830 R18580 110374-16- N/A $457.00 IN Chemical 25 EACH 2933399095 VIAL No No
dimethylpyridin-2-yl)methyl)sulfinyl)-5-methoxy- utical e 8 Synthesis
1H-benzo[d]imidazole; 2-[(RS)-[(3,5- Analytical
Dimethylpyridin-2-yl)methyl]sulfinyl]-5-methoxy- Impurity
1H-benzimidazole)
1A03460 Active Desmethyl Bosentan (25 mg) (4-(tert-butyl)-N-(6- Pharmace F200D0 253688-61- N/A $1,800.00 CN Chemical 25 EACH 2935909550 VIAL No No
(2-hydroxyethoxy)-5-(2-hydroxyphenoxy)-[2,2'- utical 8 Synthesis
bipyrimidin]-4-yl)benzenesulfonamide) Analytical
Impurity
1A02810 Active Desmethyl Promethazine Hydrochloride (25 mg) Pharmace Promethazi F18790 60113-77-1 N/A $850.00 CN Chemical 25 EACH 2934305050 VIAL No No
(N-methyl-1-(10H-phenothiazin-10-yl)propan-2- utical ne Synthesis
amine, hydrochloride) Analytical
Impurity

Page 25
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A01420 Active Desonide 21-Acetate (2- Pharmace Budesonid F17570 25092-25-5 N/A $600.00 CN Chemical 25 EACH 2932999000 VIAL No No
((6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-7- utical e Synthesis
Hydroxy-6a,8a,10,10-tetramethyl-4-oxo- Analytical
1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro- Impurity
8bH-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8b-
yl)-2-oxoethyl acetate)
1A00220 Active Desoximetasone Acid (25 mg) (COLD Pharmace Dexametha F162L0 75262-69-0 N/A $378.00 IN Chemical 25 EACH 2918992090 Cold Shipment VIAL No No
SHIPMENT) ((11Beta,16alpha,17Beta)-9-Fluoro- utical sone Synthesis Required
11-hydroxy-16-methyl-3-oxoandrosta-1,4- diene- Analytical
17-carboxylic acid; 9-Fluoro-11Beta-hydroxy- Impurity
16alpha-methyl-3-oxoandrosta-1,4-diene-17Beta-
carboxylic acid)
1A01480 Active Desthiophenerivaroxaban Methylcarbamate Pharmace Rivaroxaba F17700 1838139- N/A $1,200.00 CN Chemical 25 EACH 2934990005 VIAL No No
Analog (25 mg) (methyl ((2-oxo-3-(4-(3- utical n 08-4 Synthesis
oxomorpholino)phenyl)oxazolidin-5- Analytical
yl)methyl)carbamate) Impurity
1A01500 Active Desthiophenerivaroxaban Phthalimodo Analog (25 Pharmace Rivaroxaba F17720 1424944- N/A $880.00 CN Chemical 25 EACH 2934990005 VIAL No No
mg) ((R)-2-((2-oxo-3-(4-(3- utical n 35-3 Synthesis
oxomorpholino)phenyl)oxazolidin-5- Analytical
yl)methyl)isoindoline-1,3-dione) Impurity
1A00340 Active Dexamethasone Ethyl Ester (25 mg) (COLD Pharmace Dexametha F169D0 37926-77-5 N/A $400.00 IN Chemical 25 EACH 2918992090 Cold Shipment VIAL No No
SHIPMENT REQUIRED) (Ethyl 11Beta,17alpha- utical sone Synthesis Required
dihydroxy-9-fluoro-16alpha-methylandrostane-1,4- Analytical
diene-3-one-17-ylcarboxylate) Impurity
1A00300 Active Dexamethasone Formate (25 mg) (COLD Pharmace Dexametha F169B0 473273-04- N/A $400.00 IN Chemical 25 EACH 2918992090 VIAL No No
SHIPMENT REQUIRED) utical sone 0 Synthesis
((8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-17- Analytical
(formyloxy)-11-hydroxy-10,13,16-trimethyl-3-oxo- Impurity
6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-
cyclopenta[a]phenanthrene-17-carboxylic acid)
1A00770 Active Diamino Atorvastatin Calcium (25 mg) (Calcium Pharmace Atorvastati F177Q0 1105067- N/A $700.00 IN Chemical 25 EACH 2933998350 VIAL No No
(3R,5R)-7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1- utical n Calcium 87-5 Synthesis
methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H- Analytical
pyrrol-1-yl]-3,5-dihydroxyheptanoyl]amino]-3,5- Impurity
dihydroxyheptanoate)
1A03260 Active Dibenzazepinodione (50 mg) (5H- Pharmace F19510 19579-83-0 N/A $1,100.00 CN Chemical 50 EACH 2933998350 VIAL No No

Page 26
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
dibenzo[b,f]azepine-10,11-dione) utical Synthesis
Analytical
Impurity
1A02260 Active Dichlorothienoic Acid (25 mg) (4,5- Pharmace Rivaroxaba F182G0 31166-29-7 N/A $1,100.00 CN Chemical 25 EACH 2934990005 VIAL No No
dichlorothiophene-2-carboxylic acid) utical n Synthesis
Analytical
Impurity
1A01580 Active Dichlorothiophene Carboxylic Acid (25 mg) (3,5- Pharmace Rivaroxaba F17790 89166-94-9 N/A $770.00 CN Chemical 25 EACH 2934990005 VIAL No No
dichlorothiophene-2-carboxylic acid) utical n Synthesis
Analytical
Impurity
1A02400 Active Diisobutyl Diazecinedione (25 mg) (4,9-Diisobutyl- Pharmace Pregabalin F184T0 1990538- N/A $1,900.00 IN Chemical 25 EACH 2933790002 VIAL No No
1,6-diazecane-2,7-dione) utical 03-8 Synthesis
Analytical
Impurity
1A01950 Active Dimethylacrylamide tolyl ketone (25 mg) ((2E)- Pharmace Zolpidem F187F0 N/A N/A $880.00 IN Chemical 25 EACH 2924296000 VIAL No No
N,N-dimethyl-4-(4-methylphenyl)-4-oxobut-2- utical Tartrate Synthesis
enamide) Analytical
Impurity
1A01320 Active Dimethylethylamine Hydrochloride (25 mg) (N,N- Pharmace Clavulanat F17520 58114-25-3 N/A $700.00 CN Chemical 25 EACH 2921196190 VIAL No No
dimethylethanamine, hydrochloride) utical e Synthesis
Analytical Potassium
Impurity
1A02770 Active Dimethylketoprofen (COLD SHIPMENT Pharmace Ketoprofen F19700 1785759- N/A $850.00 IN Chemical 25 EACH 2918300000 VIAL No No
REQUIRED) (25 mg) ((2RS)-2-[3-(2,4- utical 59-2 Synthesis
Dimethylbenzoyl)phenyl]propanoic Acid) Analytical
Impurity
1A01600 Active Diphthalimido Morpholinone Analog (25 mg) (2,2'- Pharmace Rivaroxaba F177B0 1643354- N/A $880.00 CN Chemical 25 EACH 2934990005 VIAL No No
((2R,2'R)-((4-(3- utical n 27-1 Synthesis
oxomorpholino)phenyl)azanediyl)bis(2- Analytical
hydroxypropane-3,1-diyl))bis(isoindoline-1,3- Impurity
dione))
1A03720 Active Dithienyl glycolic acid Pharmace Coming 4746-63-8 N/A Coming EACH 2934990005 No No
utical Soon Soon
Analytical
Impurity

Page 27
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A00250 Active Donepezil Quaternary Salt (Donepezilbenzyl Pharmace Donepezil R178C0 F16030 844694-85- N/A $670.00 CN Chemical 25 EACH 2933399095 VIAL No No
Bromide) (25 mg) (1,1-dibenzyl-4-((5,6-dimethoxy- utical Hydrochlori 5 Synthesis
1-oxo-2,3-dihydro-1H-inden-2-yl)methyl)piperidin- Analytical de
1-ium, bromide; 1,1-dibenzyl-4-[(5,6-dimethoxy-1- Impurity
oxoindan-2-yl)methyl]piperidinium, bromide)
1A05080 Active Drospirenone Lactol Pharmace Coming 863329-71- N/A Coming EACH 2932190002 No No
utical Soon 9 Soon
Analytical
Impurity
1A00940 Active Duloxetine 4-Naphthyl Isomer Hydrobromide (25 Pharmace Duloxetine F173T0 949096-01- N/A $880.00 CN Chemical 25 EACH 2934990005 VIAL No No
mg) (4-(3-(methylamino)-1-(thiophen-2- utical 9 Synthesis
yl)propyl)naphthalen-1-ol, hydrobromide) Analytical
Impurity
1A00960 Active Duloxetine Alcohol (25 mg) ((R)-3-(methylamino)- Pharmace Duloxetine F173U0 116539-57- N/A $690.00 CN Chemical 25 EACH 2934990005 VIAL No No
1-(thiophen-2-yl)propan-1-ol) utical 2 Synthesis
Analytical
Impurity
1A02170 Active Duloxetine Phenylcarbamate (50 mg) (phenyl (S)- Pharmace Duloxetine F18350 947686-09- N/A $700.00 CN Chemical 50 EACH 2934990005 VIAL No No
methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2- utical 1 Synthesis
yl)propyl)carbamate) Analytical
Impurity
1A02190 Active Duloxetine Phthalamide (25 mg) ((S)-2-(methyl(3- Pharmace Duloxetine F18360 199191-67- N/A $770.00 25 EACH 2934990005 No No
(naphthalen-1-yloxy)-3-(thiophen-2- utical 8
yl)propyl)carbamoyl)benzoic acid) Analytical
Impurity
1A02200 Active Duloxetine Regioisomer (25 mg) (2-(2-(3- Pharmace Duloxetine F184P0 940291-11- N/A $800.00 CN Chemical 25 EACH 2934990005 VIAL No No
(methylamino)propyl)thiophen-3-yl)naphthalen-1- utical 2 Synthesis
ol) Analytical
Impurity
1A00950 Active Duloxetine beta-Naphthol-1-yl Isomer (50 mg) (2- Pharmace Duloxetine R204Q0 F177R0 1033803- N/A $900.00 CN Chemical 50 EACH 2934990005 VIAL No No
(3-(Methylamino)-1-(thiophen-2- utical 59-6 Synthesis
yl)propyl)naphthalen-1-ol) Analytical
Impurity
1A02690 Active E-Cefepime (25 mg) (1-({(6R,7R)-7-[(E)-2-(2- Pharmace Cefepime F203K0 N/A N/A $2,500.00 IN Chemical 25 EACH 2934100000 VIAL No No
Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-2- utical hydrochlori Synthesis
carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en- Analytical de

Page 28
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
3-yl}methyl)-1-methylpyrrolidinium chloride) Impurity
1A04610 Active Emtricitabine 2-Epimer (25 mg) (4-amino-5-fluoro- Pharmace Coming 145416-34- N/A Coming 25 EACH 2934990005 No No
1-((2S,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5- utical Soon 8 Soon
yl)pyrimidin-2(1H)-one; 5-Fluoro-1-[(2S,5S)-2- Analytical
(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine) Impurity
1A04620 Active Emtricitabine Enantiomer (25 mg) (4-amino-5- Pharmace F20820 137530-41- N/A $1,650.00 IN Chemical 25 EACH 2934990005 VIAL No No
fluoro-1-((2S,5R)-2-(hydroxymethyl)-1,3- utical 7 Synthesis
oxathiolan-5-yl)pyrimidin-2(1H)-one; Analytical
5-Fluoro-1-[(2S,5R)-2-(hydroxymethyl)-1,3- Impurity
oxathiolan-5-yl]cytosine)
1A05090 Active Emtricitabine Sulfoxide Pharmace Coming 152128-77- N/A Coming EACH 2934990005 No No
utical Soon 3 Soon
Analytical
Impurity
1A02740 Active Epinephrine Hydrochloride Methoxy Analog (25 Pharmace Epinephrin F18780 74571-90-7 N/A $1,200.00 25 EACH 2922504500 No No
mg) (4-(1-methoxy-2-(methylamino)ethyl)benzene- utical e
1,2-diol, hydrochloride) Analytical
Impurity
1A01780 Active Escitalopram Acid Analog (25 mg) (1-(3- Pharmace Escitalopra F180N0 440121-09- N/A $800.00 IN Chemical 25 EACH 2932996560 VIAL No No
(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3- utical m 5 Synthesis
dihydroisobenzofuran-5-carboxylic acid) Analytical
Impurity
1A01760 Active Escitalopram Open Ring (25 mg) (4-[4- Pharmace Escitalopra F17820 103146-25- N/A $440.00 IN Chemical UN3077 25 EACH 2926900005 VIAL No No
(Dimethylamino)-1-(4-fluorophenyl)-1- utical m 4 Synthesis
hydroxybutyl]-3-(hydroxymethyl)benzonitrile) Analytical
Impurity
1A00360 Active Ethylpyrazinediethanol (10 mg) (2,2'-(3- Pharmace Clavulanat F167Y0 86917-74-0 N/A $1,800.00 CN Chemical 10 EACH 2933998350 VIAL No No
ethylpyrazine-2,5-diyl)bis(ethan-1-ol)) utical e Synthesis
Analytical Potassium
Impurity
1A00980 Active Fexofenadine Chloro Analog (25 mg) (Methyl 4-(4- Pharmace Fexofenadi F178H0 154477-54- N/A $700.00 IN Chemical 25 EACH 2918300000 VIAL No No
Chloro-1-oxobutyl)-alpha,alpha- utical ne 0 Synthesis
dimethylphenylacetate) Analytical
Impurity
1A01920 Active Fexofenadine N-oxide (25 mg) (1-(4-(4-(2- Pharmace Fexofenadi F179L0 1422515- N/A $1,200.00 CN Chemical 25 EACH 2933399095 VIAL No No

Page 29
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
carboxypropan-2-yl)phenyl)-4-hydroxybutyl)-4- utical ne 52-3 Synthesis
(hydroxydiphenylmethyl)piperidine 1-oxide) Analytical
Impurity
1A00731 Active Fexofenadine Olefin (25 mg) (2-(4-(4-(4- Pharmace Fexofenadi F17290 1187954- N/A $900.00 CN Chemical 25 EACH 2933399095 VIAL No No
(diphenylmethylene)piperidin-1-yl)-1- utical ne 57-9 Synthesis
hydroxybutyl)phenyl)-2-methylpropanoic acid) Analytical
Impurity
1A03570 Active Fingolimod decyl homolog (25 mg) (2-amino-2-(4- Pharmace F20170 780729-32- N/A $1,350.00 CN Chemical 25 EACH 2922199695 VIAL No No
decylphenethyl)propane-1,3-diol) utical 0 Synthesis
Analytical
Impurity
1A03550 Active Fingolimod heptyl homolog (25 mg) (2-amino-2-(4- Pharmace F202S0 745767-97- N/A $1,350.00 CN Chemical 25 EACH 2922199695 VIAL No No
heptylphenethyl)propane-1,3-diol) utical 9 Synthesis
Analytical
Impurity
1A03560 Active Fingolimod hexyl homolog (25 mg) (2-amino-2-(4- Pharmace F20160 1201794- N/A $1,350.00 CN Chemical 25 EACH 2922199695 VIAL No No
hexylphenethyl)propane-1,3-diol) utical 93-5 Synthesis
Analytical
Impurity
1A03540 Active Fingolimod nonyl homolog (25 mg) (2-amino-2-(4- Pharmace F20150 746594-44- N/A $750.00 CN Chemical 25 EACH 2922199695 VIAL No No
nonylphenethyl)propane-1,3-diol) utical 5 Synthesis
Analytical
Impurity
1A01000 Active Floxacin Amine (25 mg) (7-amino-1-cyclopropyl-6- Pharmace Moxifloxaci F174M0 172426-88- N/A $900.00 CN Chemical 25 EACH 2933497050 VIAL No No
fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3- utical n 9 Synthesis
carboxylic acid) Analytical
Impurity
1A00120 Active Fluoroandrostadiene Carboxylic Acid (25 mg) Pharmace Dexametha F159R0 37927-01-8 N/A $600.00 CN Chemical 25 EACH 2918992090 VIAL No No
((8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro- utical sone Synthesis
11,17-dihydroxy-10,13,16-trimethyl-3-oxo- Analytical
6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H- Impurity
cyclopenta[a]phenanthrene-17-carboxylic acid)
1A04650 Active Fluticasone Furoate 17-Carboxylic Acid Pharmace Coming 397864-63- N/A Coming EACH 2932190002 No No
utical Soon 0 Soon
Analytical
Impurity

Page 30
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A04660 Active Fluticasone Oxathiolane Pharmace Coming 219719-95- N/A Coming EACH 2934990005 No No
utical Soon 6 Soon
Analytical
Impurity
1A00700 Active Fluticasone Propionate Acid (25 mg) Pharmace Fluticasone F172M0 65429-42-7 N/A $770.00 CN Chemical 25 EACH 2918992090 VIAL No No
((6S,8S,9R,10S,11S,13S,14S,16R,17R)-6,9- utical Propionate Synthesis
difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17- Analytical
(propionyloxy)-6,7,8,9,10,11,12,13,14,15, 16,17- Impurity
dodecahydro-3H-cyclopenta[a]phenanthrene-17-
carboxylic acid)
1A04630 Active Fluticasone Propionate Thioacid Pharmace Coming 80474-45-9 N/A Coming EACH 2930909265 No No
utical Soon Soon
Analytical
Impurity
1A01130 Active Fluticasone Propionate Trisulfide (25 mg) Pharmace Fluticasone F176V0 960071-64- N/A $1,700.00 CN Chemical 25 EACH 2930909265 VIAL No No
utical Propionate 1 Synthesis
Analytical
Impurity
1A01120 Active Fluticasone sulfenic acid (25 mg) Pharmace Fluticasone F174N0 948566-12- N/A $700.00 CN Chemical 25 EACH 2930909265 VIAL No No
((6S,8S,9R,10S,11S,13S,14S,16R,17R)-6,9- utical Propionate 9 Synthesis
difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17- Analytical
(propionyloxy)-6,7,8,9,10,11,12,13,14,15,16,17- Impurity
dodecahydro-3H-cyclopenta[a]phenanthrene-17-
carbo(thioperoxoic )O-acid)
1A03670 Active Fulvestrant sulfone (25 mg) Pharmace F203W0 98008-06-1 N/A $1,150.00 CN Chemical 25 EACH 2930902000 VIAL No No
((7R,8R,9S,13S,14S,17S)-13-methyl-7-(9- utical Synthesis
((4,4,5,5,5- Analytical
pentafluoropentyl)sulfonyl)nonyl)7,8,9,11,12,13,14 Impurity
,15,16,17-decahydro-6H-
cyclopenta[a]phenanthrene-3,17-diol)
1A02890 Active Guanylmelamine Dinitrate (25 mg) (1-(4,6- Pharmace Metformin F19360 27369-26-2 N/A $500.00 CN Chemical 25 EACH 2933690000 VIAL No No
diamino-1,3,5-triazin-2-yl)guanidine, nitrate) utical Hydrochlori Synthesis
Analytical de
Impurity
1A03110 Active Hydroxy Ivabradine (25 mg) (3-(3-hydroxypropyl)- Pharmace Ivabradine F189U0 1235547- N/A $950.00 CN Chemical 25 EACH 2933790002 VIAL No No
7,8-dimethoxy-1,3,4,5-tetrahydro-2H- utical Hydrochori 07-5 Synthesis

Page 31
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
benzo[d]azepin-2-one) Analytical de
Impurity
1A04930 Active Hydroxybenzoyl Paliperidone Pharmace Coming 152542-03- N/A Coming EACH 2933599550 No No
utical Soon 5 Soon
Analytical
Impurity
1A00310 Active Hydroxyisobutyl Acetophenone (25 mg) (COLD Pharmace Ibuprofen F169C0 1314907- N/A $350.00 IN Chemical 25 EACH 2914404000 VIAL No No
SHIPMENT REQUIRED) (1-(4-(1-hydroxy-2- utical 71-5 Synthesis
methylpropyl)phenyl)ethan-1-one) Analytical
Impurity
1A00040 Active Hydroxythiadiazol Sulfoxide Derivative (25 mg) (4- Pharmace Timolol R184K0 F15960 75202-36-7 N/A $600.00 CN Chemical 25 EACH 2934990005 VIAL No No
morpholino-1,2,5-thiadiazol-3(2H)-one 1-oxide) utical Synthesis
Analytical
Impurity
1A00480 Active Ibuprofen Tetraethylene Glycol Diester (25 mg) Pharmace Ibuprofen F16880 1161014- N/A $350.00 CN Chemical 25 EACH 2918992090 VIAL No No
(((oxybis(ethane-2,1-diyl))bis(oxy))bis(ethane-2,1- utical 75-0 Synthesis
diyl) bis(2-(4-isobutylphenyl)propanoate))) Analytical
Impurity
1A01910 Active Iodofluticasone Propionate (25 mg) Pharmace Fluticasone F179K0 80474-67-5 N/A $1,100.00 CN Chemical 25 EACH 2930902000 VIAL No No
utical Propionate Synthesis
Analytical
Impurity
1A01840 Active Isobutylglutarmonoamide (25 mg) (3-(2-Amino-2- Pharmace Pregabalin F17870 181289-15- N/A $600.00 IN Chemical 25 EACH 2924190002 VIAL No No
oxoethyl)-5-methylhexanoic Acid) utical 6 Synthesis
Analytical
Impurity
1A01830 Active Isobutylglutarmonoamide (R-isomer) (25 mg) ((R)- Pharmace Pregabalin F180P0 181289-33- N/A $1,500.00 IN Chemical 25 EACH 2924190002 VIAL No No
3-(2-amino-2-oxoethyl)-5-methylhexanoic acid) utical 8 Synthesis
Analytical
Impurity
1A03320 Active Isocyclosporin A (COLD SHIPMENT REQUIRED) Pharmace Coming 59865-16-6 N/A Coming EACH 2933790002 No No
utical Soon Soon
Analytical
Impurity
1A00290 Active Isopropyl 4-acetylbenzoate (COLD SHIPMENT Pharmace Ibuprofen F169A0 220089-22- N/A $150.00 IN Chemical 25 EACH 2918300000 AMPULE No No
REQUIRED) (25 mg) (Isopropyl 4-acetylbenzoate) utical 5 Synthesis

Page 32
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
Analytical
Impurity
1A02050 Active Isotachysterol3 (25 mg) (COLD SHIPMENT Pharmace Cholecalcif F183X0 22350-43-2 N/A $1,100.00 IN Chemical 25 EACH 2906195000 Cold Shipment VIAL No No
REQUIRED) (S)-4-methyl-3-((E)-2-((1R,7aR)-7a- utical erol Synthesis Required
methyl-1-((R)-6-methylheptan-2-yl)-2,3,5,6,7,7a- Analytical
hexahydro-1H-inden-4-yl)vinyl)cyclohex-3-en-1-ol) Impurity
1A02940 Active Ivabradine Amine Hydrochloride (25 mg) ((S)-1- Pharmace Ivabradine F189Y0 866783-13- N/A $750.00 CN Chemical 25 EACH 2922299000 VIAL No No
(3,4-dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7- utical Hydrochori 3 Synthesis
yl)-N-methylmethanamine, hydrochloride) Analytical de
Impurity
1A03160 Active Ivabradine Bisbenzazepine Analog (25 mg) (3,3'- Pharmace Ivabradine F189X0 2731089- N/A $1,100.00 CN Chemical 25 EACH 2933790002 VIAL No No
(propane-1,3-diyl)bis(7,8-dimethoxy-1,3,4,5- utical Hydrochori 65-7 Synthesis
tetrahydro-2H-benzo[d]azepin-2-one)) Analytical de
Impurity
1A03150 Active Ivabradine Chloroveratryl Analog Hydrochloride Pharmace F189W0 N/A N/A $2,000.00 CN Chemical 25 EACH 2933790002 VIAL No No
(25 mg) (3-(3-((3-chloro-2-(3,4- utical Synthesis
dimethoxyphenyl)propyl)(methyl)amino)propyl)- Analytical
7,8-dimethoxy-1,3,4,5-tetrahydro-2H- Impurity
benzo[d]azepin-2-one, hydrochloride)
1A03090 Active Ivabradine N-Oxide (25 mg) (3-(7,8-dimethoxy-2- Pharmace Ivabradine F189Q0 2511244- N/A $900.00 CN Chemical 25 EACH 2933790002 VIAL No No
oxo-1,2,4,5-tetrahydro-3H-benzo[d]azepin-3-yl)-N- utical Hydrochori 97-4 Synthesis
(((S)-3,4-dimethoxybicyclo[4.2.0]octa-1(6),2,4- Analytical de
trien-7-yl)methyl)-N-methylpropan-1-amine oxide) Impurity
1A03130 Active Ivabradine Open Ring (25 mg) ((S)-2-(2-(2-((3- Pharmace Ivabradine F193G0 1462470- N/A $900.00 CN Chemical 25 EACH 2922504500 VIAL No No
(((3,4-dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7- utical Hydrochori 54-7 Synthesis
yl)methyl)(methyl)amino)propyl)amino)ethyl)-4,5- Analytical de
dimethoxyphenyl)acetic acid) Impurity
1A03120 Active Ivabradine R-Enantiomer Hydrochloride (25 mg) Pharmace Ivabradine F189V0 148849-68- N/A $1,800.00 CN Chemical 25 EACH 2933790002 VIAL No No
((R)-3-(3-(((3,4-dimethoxybicyclo[4.2.0]octa- utical Hydrochori 7 Synthesis
1(6),2,4-trien-7-yl)methyl)(methyl)amino)propyl)- Analytical de
7,8-dimethoxy-1,3,4,5-tetrahydro-2H- Impurity
benzo[d]azepin-2-one, hydrochloride)
1A03140 Active Ivabradine Veratryl Analog Hydrochloride (25 mg) Pharmace Ivabradine F193H0 N/A N/A $1,500.00 CN Chemical 25 EACH 2933790002 VIAL No No
(3-(3-((2-(3,4- utical Hydrochori Synthesis
dimethoxyphenyl)propyl)(methyl)amino)propyl)- Analytical de
7,8-dimethoxy-1,3,4,5-tetrahydro-2H- Impurity

Page 33
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
benzo[d]azepin-2-one, hydrochloride)
1A04770 Active Ketovarenicline Trifluoroacetate (25 mg) (rel- Pharmace F207K0 357426-10- N/A $975.00 CN Chemical 25 EACH 2933998350 VIAL No No
(6S,10R)-8-(2,2,2-trifluoroacetyl)-1,6,7,8,9,10- utical 9 Synthesis
hexahydro-2H-6,10-methanoazepino[4,5- Analytical
g]quinoxalin-2-one) Impurity
1A04500 Active L-Glucono-delta-lactone (25 mg) ((3S,4R,5R,6S)- Pharmace F20690 52153-09-0 N/A $750.00 CN Chemical 25 EACH 2932206000 VIAL No No
3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H- utical Synthesis
pyran-2-one) Analytical
Impurity
1A01800 Active Lacosamide Acrylamide Analog (25 mg) (2- Pharmace Lacosamid F17840 86921-49-5 N/A $700.00 IN Chemical 25 EACH 2924296000 VIAL No No
Acetamido-N-benzylacrylamide) utical e Synthesis
Analytical
Impurity
1A02340 Active Lactosyl Pregabalin Pyrrolidone (25 mg) ((S)-1- Pharmace Pregabalin F18430 466678-44- N/A $2,000.00 IN Chemical 25 EACH 2933790002 VIAL No No
((2R,3R,4R,5S,6R)-3,4-dihydroxy-6- utical 4 Synthesis
(hydroxymethyl)-5-(((2S,3R,4S,5R,6R)-3,4,5- Analytical
trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran- Impurity
2-yl)oxy)tetrahydro-2H-pyran-2-yl)-4-
isobutylpyrrolidin-2-one)
1A05120 Active Lamivudine R-sulfoxide Pharmace Coming 160552-54- N/A Coming EACH 2934990005 No No
utical Soon 5 Soon
Analytical
Impurity
1A05130 Active Lamivudine Uracil Derivative Pharmace Coming 145986-07- N/A Coming EACH 2934990005 No No
utical Soon 8 Soon
Analytical
Impurity
1A04780 Active Lenalidomide Open Ring (25 mg) (2-(4-Amino-1,3- Pharmace F207F0 2197414- N/A $1,300.00 IN Chemical 25 EACH 2933790002 VIAL No No
dihydro-1-oxo-2H-isoindol-2-yl)pentanediamide) utical 55-2 Synthesis
Analytical
Impurity
1A04790 Active Lenalidomide Open Ring Diacid (25 mg) (2-(4- Pharmace F207H0 295357-66- N/A $550.00 IN Chemical 25 EACH 2933790002 VIAL No No
amino-1-oxoisoindolin-2-yl)pentanedioic acid) utical 3 Synthesis
Analytical
Impurity

Page 34
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A03800 Active Lenvatinib N-Oxide (25 mg) (6-carbamoyl-4-(3- Pharmace F206M0 1788901- N/A $1,750.00 CN Chemical 25 EACH 2933497050 VIAL No No
chloro-4-(3-cyclopropylureido)phenoxy)-7- utical 86-9 Synthesis
methoxyquinoline 1-oxide) Analytical
Impurity
1A01960 Active Levamlodipine (25 mg) (3-ethyl 5-methyl (S)-2-((2- Pharmace Amlodipine F18310 103129-82- N/A $600.00 IN Chemical 25 EACH 2933399095 VIAL No No
aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl- utical 4 Synthesis
1,4-dihydropyridine-3,5-dicarboxylate) Analytical
Impurity
1A02220 Active Levetiracetam Crotonamide (10 mg) ((Z)-2-(2- Pharmace Levetiracet F182D0 358629-47- N/A $750.00 CN Chemical 10 EACH 2933790002 VIAL No No
oxopyrrolidin-1-yl)but-2-enamide) utical am 7 Synthesis
Analytical
Impurity
1A02390 Active Mannityl Amlodipine (25 mg) (3-Ethyl 5-methyl 4- Pharmace Amlodipine F197H0 N/A N/A $600.00 IN Chemical 25 EACH 2933399095 VIAL No No
(2-chlorophenyl)-6-methyl-2-((2-(((2R,3R,4R,5R)- utical Synthesis
2,3,4,5,6- Analytical
pentahydroxyhexyl)amino)ethoxy)methyl)-1,4- Impurity
dihydropyridine-3,5-dicarboxylate)
1A03600 Active Mebetide (25 mg) (3-methyl-2H- Pharmace F20250 360-81-6 N/A $600.00 CN Chemical 25 EACH 2934990005 VIAL No No
benzo[e][1,2,4]thiadiazine 1,1-dioxide) utical Synthesis
Analytical
Impurity
1A00710 Active Methoxyamiodarone (25 mg) ([2-[(1RS)-1- Pharmace Amiodaron F194P0 1087223- N/A $3,800.00 IN Chemical 25 EACH 2932996560 VIAL No No
Methoxybutyl]benzofuran-3-yl][4-[2- utical e 70-8 Synthesis
(diethylamino)ethoxy]-3,5- Analytical
diiodophenyl]methanone) Impurity
1A01940 Active Methoxycyclohexanol methacrylic aldehyde (25 Pharmace Tacrolimus F180Q0 109466-74- N/A $700.00 CN Chemical 25 EACH 2912499500 VIAL No No
mg) ((E)-3-((1R,3R,4R)-4-hydroxy-3- utical 2 Synthesis
methoxycyclohexyl)-2-methylacrylaldehyde) Analytical
Impurity
1A01710 Active Methyl 2-chloro-Beta-D-phenylalanine (25 mg) Pharmace Clopidogrel F177J0 212838-70- N/A $1,000.00 CN Chemical 25 EACH 2922493800 VIAL No No
(methyl (R)-2-amino-2-(2-chlorophenyl)acetate, utical Bisulfate 5 Synthesis
hydrochloride) Analytical
Impurity
1A05100 Active Methyl Dithienyl glycolate Pharmace Coming 26447-85-8 N/A Coming EACH 2934990005 No No
utical Soon Soon
Analytical

Page 35
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
Impurity
1A03350 Active Methyl Varenicline (25 mg) (rel-(6S,10R)-2- Pharmace F199P0 1333145- N/A $1,900.00 CN Chemical 25 EACH 2933998350 VIAL No No
methyl-7,8,9,10-tetrahydro-6H-6,10- utical 89-3 Synthesis
methanoazepino[4,5-g]quinoxaline) Analytical
Impurity
1A00930 Active Methyl p-Toluate (25 mg) (Methyl 4- Pharmace Celecoxib F178G0 99-75-2 N/A $300.00 IN Chemical 25 EACH 2916399000 VIAL No No
methylbenzoate) utical Synthesis
Analytical
Impurity
1A01490 Active Methylisoindolinedione (25 mg) (2- Pharmace Rivaroxaba F17710 550-44-7 N/A $770.00 CN Chemical 25 EACH 2925190100 VIAL No No
methylisoindoline-1,3-dione) utical n Synthesis
Analytical
Impurity
1A05010 Active Mirabegron N-Thiazolacetyl Analog Pharmace Coming 1684452- N/A Coming EACH 2934100000 No No
utical Soon 83-2 Soon
Analytical
Impurity
1A05000 Active Mirabegron S-Enantiomer (25 mg) ((S)-2-(2- Pharmace F21030 1796931- N/A $975.00 CN Chemical 25 EACH 2934100000 VIAL No No
aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2- utical 48-0 Synthesis
phenylethyl)amino)ethyl)phenyl)acetamide) Analytical
Impurity
1A03250 Active Monochlorotriiodothyronine (25 mg) ((S)-2-Amino- Pharmace F201V0 909279-46- N/A $2,500.00 IN Chemical 25 EACH 2922504500 VIAL No No
3-[3-chloro-4-(4-hydroxy-3,5-diiodophenoxy)-5- utical 5 Synthesis
iodophenyl]propanoic acid) Analytical
Impurity
1A01090 Active Monoiodoamiodarone (50 mg) ((2- Pharmace Amiodaron R202P0 F176U0 85642-08-6 N/A $1,050.00 IN Chemical 50 EACH 2932996560 VIAL No No
Butylbenzofuran-3-yl){4-[2-(diethylamino)ethoxy]- utical e Synthesis
3-iodophenyl}methanone) Analytical
Impurity
1A04830 Active N-(2-Methoxypyrimidin-4-yl)-N,2,3-trimethyl-2H- Pharmace F208A0 1296888- N/A $475.00 IN Chemical 25 EACH 2933599550 VIAL No No
indazol-6-amine (25 mg) (N-(2-methoxypyrimidin- utical 47-5 Synthesis
4-yl)-N,2,3-trimethyl-2H-indazol-6-amine) Analytical
Impurity
1A01670 Active N-Acetyl Desloratadine (25 mg) (1-[4-(8-Chloro- Pharmace Desloratadi F177Y0 117796-52- N/A $770.00 IN Chemical 25 EACH 2933399095 VIAL No No
5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2- utical ne 8 Synthesis

Page 36
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
b]pyridin-11-ylidene)-1-piperidinyl]ethanone) Analytical
Impurity
1A03660 Active N-Acetyl Lenalidomide (25 mg) (N-(2-(2,6- Pharmace F20190 1421593- N/A $1,250.00 CN Chemical 25 EACH 2933790002 VIAL No No
dioxopiperidin-3-yl)-1-oxoisoindolin-4- utical 80-7 Synthesis
yl)acetamide) Analytical
Impurity
1A04870 Active N-Acetyl Linagliptin Pharmace Coming 1803079- N/A Coming EACH 2933599550 No No
utical Soon 49-3 Soon
Analytical
Impurity
1A02500 Active N-Alkyl Aripiprazole (25 mg) (7-(4-(4-(2,3- Pharmace Aripiprazol F184V0 1424857- N/A $1,400.00 CN Chemical 25 EACH 2933790002 VIAL No No
dichlorophenyl)piperazin-1-yl)butoxy)-1-(4-((2-oxo- utical e 63-5 Synthesis
1,2,3,4-tetrahydroquinolin-7-yl)oxy)butyl)-3,4- Analytical
dihydroquinolin-2(1H)-one) Impurity
1A04600 Active N-Alkyl Brexpiprazole (25 mg) (7-(4-(4- Pharmace F207Y0 2094559- N/A $875.00 IN Chemical 25 EACH 2934990005 VIAL No No
(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)-1-(4- utical 58-5 Synthesis
((2-oxo- 1,2- dihydroquinolin-7- Analytical
yl)oxy)butyl)quinolin-2(1H)-one) Impurity
1A01810 Active N-Benzylacetamide (25 mg) (N- Pharmace Lacosamid F17850 588-46-5 N/A $700.00 IN Chemical 25 EACH 2924296000 VIAL No No
Acetylbenzylamine) utical e Synthesis
Analytical
Impurity
1A02960 Active N-Desmethyl Ivabradine Hydrochloride (25 mg) (3- Pharmace Ivabradine F19000 1246638- N/A $1,000.00 CN Chemical 25 EACH 2933790002 VIAL No No
[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5- utical Hydrochori 08-3 Synthesis
trien-7-yl]methyl]amino]propyl]-1,3,4,5-tetrahydro- Analytical de
7,8-dimethoxy-2H-3-benzazepin-2-one, Impurity
hydrochloride)
1A00180 Active N-Ethyl Quetiapine (25 mg) (11-(4-Ethylpiperazin- Pharmace Quetiapine R187J0 F158V0 NA N/A $750.00 IN Chemical 25 EACH 2934990005 VIAL No No
1-yl)dibenzo[b,f][1,4]thiazepine hydrochloride) utical fumarate Synthesis
Analytical
Impurity
1A03390 Active N-Formyl Lenalidomide (25 mg) (N-(2-(2,6- Pharmace F199X0 2197414- N/A $1,650.00 CN Chemical 25 EACH 2933790002 VIAL No No
dioxopiperidin-3-yl)-1-oxoisoindoIin-4- utical 56-3 Synthesis
yl)formamide) Analytical
Impurity

Page 37
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A04740 Active N-Formyl Palbociclib (25 mg) (4-(6-((6-acetyl-8- Pharmace F207G0 2174002- N/A $1,500.00 IN Chemical 25 EACH 2933790002 VIAL No No
cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3- utical 16-3 Synthesis
d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1- Analytical
carbaldehyde) Impurity
1A01660 Active N-Hydroxy Desloratadine (25 mg) (4-(8-Chloro- Pharmace Desloratadi F177X0 1193725- N/A $900.00 IN Chemical 25 EACH 2933399095 VIAL No No
5,6-dihydro-benzo[5,6]cyclohepta[1,2-b]pyridin-11- utical ne 73-3 Synthesis
ylidene)-piperidin-1-ol) Analytical
Impurity
1A00230 Active N-Isopropyl Carvedilol (25 mg) (1-(9H-Carbazol-4- Pharmace Carvedilol F163Q0 1246819- N/A $430.00 IN Chemical 25 EACH 2933998350 VIAL No No
yloxy)-3-[[2-(2-methoxyphenoxy)ethyl](1- utical 01-1 Synthesis
methylethyl)amino]-2-propanol) Analytical
Impurity
1A02210 Active N-Methyl Duloxetine 3-Isomer Oxalate (25 mg) Pharmace Duloxetine F182C0 N/A N/A $1,650.00 CN Chemical 25 EACH 2934990005 VIAL No No
((R)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3- utical Synthesis
(thiophen-3-yl)propan-1-amine, oxalate) Analytical
Impurity
1A00970 Active N-Methyl Duloxetine Oxalate (25 mg) ((S)-N,N- Pharmace Duloxetine F173V0 132335-47- N/A $770.00 CN Chemical 25 EACH 2934990005 VIAL No No
dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-2- utical 8 Synthesis
yl)propan-1-amine, oxalate) Analytical
Impurity
1A01790 Active N-Methyl Lacosamide (25 mg) ((R)-2-(N- Pharmace Lacosamid R203H0 F17830 2742962- N/A $2,000.00 IN Chemical 25 EACH 2924296000 VIAL No No
methylacetamido)-N-benzyl-3- utical e 60-1 Synthesis
methoxypropanamide; (R)-N-Benzyl-3-methoxy-2- Analytical
(N-methylacetamido)propanamide) Impurity
1A03620 Active N-Methyl Lenalidomide (25 mg) (3-(4- Pharmace F20180 2197421- N/A $1,200.00 CN Chemical 25 EACH 2933790002 VIAL No No
(methylamino)-1-oxoisoindolin-2-yl)piperidine-2,6- utical 58-0 Synthesis
dione) Analytical
Impurity
1A03360 Active N-Methyl Varenicline (25 mg) (7,8,9,10-tetrahydro- Pharmace F199Q0 328055-92- N/A $1,100.00 CN Chemical 25 EACH 2933998350 VIAL No No
8-methyl-6,10-Methano-6H-pyrazino[2,3- utical 1 Synthesis
h][3]benzazepine) Analytical
Impurity
1A02310 Active N-Methyl rac-Lacosamide (25 mg) (2-acetamido- Pharmace Lacosamid F18410 388619-64- N/A $900.00 IN Chemical 25 EACH 2924296000 VIAL No No
N-benzyl-3-methoxy-N-methylpropanamide) utical e 5 Synthesis
Analytical
Impurity

Page 38
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A04220 Active N-Nitroso Atenolol Solution (1 mL (1 mg/mL)) (2- Pharmace F204B0 134720-04- N/A $422.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
(4-(2-hydroxy-3- utical 0 Synthesis
(isopropyl(nitroso)amino)propoxy)phenyl)acetamid Analytical
e) Impurity
1A04250 Active N-Nitroso Bisoprolol Solution (1 mL (1 mg/mL)) Pharmace F204D0 2820170- N/A $435.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
(N-(2-Hydroxy-3-(4-((2- utical 76-9 Synthesis
isopropoxyethoxy)methyl)phenoxy)propyl)-N- Analytical
isopropylnitrous amide) Impurity
1A04210 Active N-Nitroso Carvedilol Solution (1 mL (1 mg/mL)) Pharmace Coming 2248746- N/A Coming UN1230 EACH 3822190000 No No
utical Soon 67-8 Soon
Analytical
Impurity
1A04380 Active N-Nitroso Dabigatran Etexilate (10 mg) (ethyl 3-(2- Pharmace F206A0 2892260- N/A $495.00 IN Chemical 10 EACH 2933399095 VIAL No No
(((4-(N- utical 29-4 Synthesis
((hexyloxy)carbonyl)carbamimidoyl)phenyl)(nitroso Analytical
)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H- Impurity
benzo[d]imidazole-5-carboxamido)propanoate)
1A04040 Active N-Nitroso Dabigatran Etexilate Solution (1 mL (1 Pharmace Coming N/A N/A Coming UN1648 EACH 2933399095 No No
mg/mL)) utical Soon Soon
Analytical
Impurity
1A04000 Active N-Nitroso Duloxetine Solution (1 mL (1 mg/mL)) Pharmace Coming 2680527- N/A Coming UN1230 EACH 3822190000 No No
utical Soon 91-5 Soon
Analytical
Impurity
1A04240 Active N-Nitroso Labetalol Solution (1 mL (1 mg/mL)) (2- Pharmace F204T0 2820170- N/A $412.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
hydroxy-5-(1-hydroxy-2-(nitroso(4-phenylbutan-2- utical 74-7 Synthesis
yl)amino)ethyl) benzamide) Analytical
Impurity
1A04200 Active N-Nitroso Metoprolol Solution (1 mL (1 mg/mL)) Pharmace F204S0 138768-62- N/A $440.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
(N-(2-hydroxy-3-(4-(2- utical 4 Synthesis
methoxyethyl)phenoxy)propyl)-N-isopropylnitrous Analytical
amide) Impurity
1A03980 Active N-Nitroso Nortriptyline Solution (1 mL (1 mg/mL)) Pharmace F201W0 55855-42-0 N/A $395.00 CA Chemical UN1230 1 EACH 3822190000 AMPULE No No
(N-(3-(10,11-Dihydro-5H-dibenzo[a,d][7]annulen- utical Synthesis
5-ylidene)propyl)-N-methylnitrous amide) Analytical

Page 39
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
Impurity
1A04230 Active N-Nitroso Propranolol Solution (1 mL (1 mg/mL)) Pharmace F204C0 84418-35-9 N/A $440.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
(1-[(1-Methylethyl)nitrosoamino]-3-(1- utical Synthesis
naphthalenyloxy)-2-propanol) Analytical
Impurity
1A04450 Active N-Nitroso Quinapril (10 mg) ((S)-2-(N-((S)-1- Pharmace F206H0 N/A N/A $530.00 IN Chemical 10 EACH 2933497050 VIAL No No
ethoxy-1-oxo-4-phenylbutan-2-yl)-N-nitroso-L- utical Synthesis
alanyl)-1,2,3,4-tetrahydroisoquinoline-3-carboxylic Analytical
acid) Impurity
1A04180 Active N-Nitroso Quinapril Solution (1 mL (1 mg/mL)) Pharmace Coming N/A N/A Coming UN1648 EACH 2933497050 No No
utical Soon Soon
Analytical
Impurity
1A04030 Active N-Nitroso Rasagiline Solution (1 mL (1 mg/mL)) Pharmace F201X0 2470278- N/A $390.00 CA Chemical UN1230 1 EACH 3822190000 AMPULE No No
((R)-N-(2,3-Dihydro-1H-inden-1-yl)-N-(prop-2-yn- utical 90-9 Synthesis
1-yl)nitrous amide) Analytical
Impurity
1A04360 Active N-Nitroso Sitagliptin Amine (NTTP) (10 mg) (7- Pharmace F207B0 2892260- N/A $480.00 IN Chemical 10 EACH 2933599550 VIAL No No
nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro- utical 32-9 Synthesis
[1,2,4]triazolo[4,3-a]pyrazine) Analytical
Impurity
1A03960 Active N-Nitroso Sitagliptin Amine (NTTP) Solution (1 mL Pharmace F20940 2892260- N/A $385.00 IN Chemical UN1230 1 EACH 2933599550 AMPULE No No
(1 mg/mL) (7-nitroso-3-(trifluoromethyl)-5,6,7,8- utical 32-9 Synthesis
tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine) Analytical
Impurity
1A04390 Active N-Nitroso Tamsulosin (10 mg) ((R)-5-(2-((2-(2- Pharmace F207C0 2892260- N/A $530.00 IN Chemical 10 EACH 2935909550 VIAL No No
ethoxyphenoxy)ethyl)(nitroso)amino)propyl)-2- utical 31-8 Synthesis
methoxybenzenesulfonamide) Analytical
Impurity
1A04090 Active N-Nitroso Tetraxetan Triacetic Acid (10 mg) Pharmace F210J0 2892260- N/A $550.00 IN Chemical 10 EACH 2933999552 VIAL No No
(2,2',2''-(10-nitroso-1,4,7,10- utical 33-0 Synthesis
tetraazacyclododecane-1,4,7-triyl)triacetic acid) Analytical
Impurity
1A03920 Active N-Nitroso Varenicline (NNV) Solution (1mL (1 Pharmace Coming 2755871- N/A Coming UN1230 EACH 2933998350 No No
mg/mL)) utical Soon 02-2 Soon

Page 40
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
Analytical
Impurity
1A03970 Active N-Nitroso-1,2,3,6-tetrahydropyridine (NTHP) Pharmace F210H0 55556-92-8 N/A $390.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
Solution (1 mL (1 mg/mL)) (1-nitroso-1,2,3,6- utical Synthesis
tetrahydropyridine) Analytical
Impurity
1A03990 Active N-Nitroso-N-methyl-2-phenylethylamine (NMPEA) Pharmace Coming 13256-11-6 N/A Coming UN1230 EACH 3822190000 No No
Solution (1 mL (1 mg/mL)) utical Soon Soon
Analytical
Impurity
1A03930 Active N-Nitrosodipropylamine (NDPA) Solution (1 mL (1 Pharmace F204R0 621-64-7 N/A $410.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
mg/mL)) (N,N-dipropylnitrous amide) utical Synthesis
Analytical
Impurity
1A04400 Active N-Nitrosoiminodiacetic acid (10 mg) (2,2'- Pharmace F20560 25081-31-6 N/A $500.00 IN Chemical 10 EACH 2929909000 VIAL No No
(nitrosoazanediyl)diacetic acid) utical Synthesis
Analytical
Impurity
1A04070 Active N-Nitrosoiminodiacetic acid Solution (1 mL (1 Pharmace Coming 25081-31-6 N/A Coming IN Chemical UN1648 1 EACH 2929909000 AMPULE No No
mg/mL)) (2,2'-(nitrosoazanediyl)diacetic acid) utical Soon Soon Synthesis
Analytical
Impurity
1A03940 Active N-Nitrosomethylphenidate (NMPH) Solution (1 mL Pharmace Coming 55557-03-4 N/A Coming UN1230 EACH 3822190000 No No
(1 mg/mL)) utical Soon Soon
Analytical
Impurity
1A03950 Active N-Nitrosopiperidine Solution (1 mL (1 mg/mL)) (1- Pharmace F200C0 100-75-4 N/A $395.00 US Chemical UN1230 1 EACH 3822190000 AMPULE No No
Nitrosopiperidine) utical Synthesis
Analytical
Impurity
1A04060 Active N-Nitrosopyrrolidine (NPYR) Solution (1 mL (1 Pharmace F20380 930-55-2 N/A $422.00 IN Chemical UN1230 1 EACH 3822190000 AMPULE No No
mg/mL) (1-Nitrosopyrrolidine)) utical Synthesis
Analytical
Impurity
1A03010 Active N-Phenoxycarbonyl Paroxetine (25 mg) (phenyl Pharmace Paroxetine F19030 253768-88- N/A $770.00 CN Chemical 25 EACH 2934990005 VIAL No No
(3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4- utical Mesylate 6 Synthesis

Page 41
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
(4-fluorophenyl)piperidine-1-carboxylate) Analytical
Impurity
1A02580 Active N1-(2-Chloroethyl)-N2-(2,3-dichlorophenyl)ethane- Pharmace Aripiprazol F18700 2748335- N/A $770.00 CN Chemical 25 EACH 2921590000 VIAL No No
1,2-diamine hydrochloride (25 mg) (N1-(2- utical e 71-7 Synthesis
chloroethyl)-N2-(2,3-dichlorophenyl)ethane-1,2- Analytical
diamine, hydrochloride) Impurity
1A00530 Active N6-(1-Iminoethyl)-D-lysine (10 mg) ((2R)-2-[(2S)- Pharmace Levetiracet F17020 1844123- N/A $450.00 CN Chemical 10 EACH 2924190002 VIAL No No
2-Aminobutanamido]butanamide) utical am 52-9 Synthesis
Analytical
Impurity
1A00390 Active Nebramine (10 mg) ((1S,2R,3R,4S,6R)-4,6- Pharmace Tobramycin R194Q0 F167T0 34051-04-2 N/A $790.00 CN Chemical 10 EACH 2932999000 VIAL No No
diamino-3-(((2R,3R,5S,6R)-3-amino-6- utical Synthesis
(aminomethyl)-5-hydroxytetrahydro-2H-pyran-2- Analytical
yl)oxy)cyclohexane-1,2-diol) Impurity
1A01590 Active Nitrophenylchlorothiophene Carboxylate (25 mg) Pharmace Rivaroxaba F177A0 1450877- N/A $880.00 CN Chemical 25 EACH 2934990005 VIAL No No
(4-nitrophenyl 5-chlorothiophene-2-carboxylate) utical n 56-1 Synthesis
Analytical
Impurity
1A03680 Active Nonylene bisestradiol (25 mg) Pharmace F202Q0 2483797- N/A $2,500.00 CN Chemical 25 EACH 2907290500 VIAL No No
(8R,8'R,9S,9'S,13S,13'S,14S,14'S,17S,17'S)-7,7'- utical 59-5 Synthesis
(nonane-1,9-diyl)bis(13-methyl- Analytical
7,8,9,11,12,13,14,15,16,17-decahydro-6H- Impurity
cyclopenta[a]phenanthrene-3,17-diol)
1A04940 Active Norbornanedicarboximide Pharmace Coming 14805-29-9 N/A Coming EACH 2925190100 No No
utical Soon Soon
Analytical
Impurity
1A03470 Active O-Acetyl Bosentan (25 mg) (2-((6-((4-(tert- Pharmace F200Q0 1160515- N/A $1,400.00 CN Chemical 25 EACH 2935909550 VIAL No No
butyl)phenyl)sulfonamido)-5-(2-methoxyphenoxy)- utical 53-6 Synthesis
[2,2'-bipyrimidin]-4-yl)oxy)ethyl acetate) Analytical
Impurity
1A04470 Active O-Desmethyl Apremilast (25 mg) ((S)-N-(2-(1-(3- Pharmace F205J0 1384441- N/A $1,100.00 IN Chemical 25 EACH 2930902000 VIAL No No
ethoxy-4-hydroxyphenyl)-2-(methylsulfonyl)ethyl)- utical 38-6 Synthesis
1,3-dioxoisoindolin-4-yl)acetamide) Analytical
Impurity

Page 42
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A03310 Active O-Desmethylmetoprolol (25 mg) (1-(4-(2- Pharmace F199L0 62572-94-5 N/A $600.00 CN Chemical 25 EACH 2922199695 VIAL No No
hydroxyethyl)phenoxy)-3-(isopropylamino)propan- utical Synthesis
2-ol) Analytical
Impurity
1A01010 Active Olanzapine lactam (25 mg) ((Z)-4-(4- Pharmace Olanzapine R202A0 F175R0 1017241- N/A $1,200.00 IN Chemical 25 EACH 2933998350 VIAL No No
methylpiperazin-1-yl)-3-(2-oxopropylidene)-1,3- utical 34-7 Synthesis
dihydro-2H-benzo[b][1,4]diazepin-2-one) Analytical
Impurity
1A01020 Active Olanzapine thiolactam (25 mg) ((Z)-1-(4-(4- Pharmace Olanzapine R202C0 F175S0 1017241- N/A $1,500.00 IN Chemical 25 EACH 2933998350 VIAL No No
Methylpiperazin-1-yl)-2-thioxo-1,2-dihydro-3H- utical 36-9 Synthesis
benzo[b][1,4]diazepin-3-ylidene)propan-2-one) Analytical
Impurity
1A01720 Active Open Ring N-Methyl Clopidogrel Hydrochloride Pharmace Clopidogrel F177K0 N/A N/A $1,450.00 CN Chemical 25 EACH 2934990005 VIAL No No
(25 mg) (methyl (S)-2-(2-chlorophenyl)-2- utical Bisulfate Synthesis
(methyl(2-(thiophen-2-yl)ethyl)amino)acetate, Analytical
hydrochloride) Impurity
1A03330 Active Orlistat Open Ring Amide (25 mg) (N-Formyl-L- Pharmace F199R0 N/A N/A $2,500.00 IN Chemical 25 EACH 2924296000 VIAL No No
leucine(S)-1-[(2S,3S)-2-hydroxy-3-[1-phenyl-R- utical Synthesis
ethyl-carbomoyl]nonyl]-dodecyl ester) Analytical
Impurity
1A03000 Active Paroxetine Hydrochloride Catechol Analog (25 Pharmace Paroxetine F193C0 1394861- N/A $750.00 CN Chemical 25 EACH 2933399095 VIAL No No
mg) (4-(((3S,4R)-4-(4-fluorophenyl)piperidin-3- utical Mesylate 12-1 Synthesis
yl)methoxy)benzene-1,2-diol, hydrochloride) Analytical
Impurity
1A02990 Active Paroxetine Hydrochloride Piperidinemethanol Pharmace Paroxetine F19020 220548-73- N/A $750.00 CN Chemical 25 EACH 2933399095 VIAL No No
Analog (25 mg) (((3S,4R)-4-(4- utical Mesylate 2 Synthesis
fluorophenyl)piperidin-3-yl)methanol, Analytical
hydrochloride) Impurity
1A03050 Active Paroxetine Methoxy Analog (25 mg) ((3R,4S)-3- Pharmace N/A N/A $2,150.00 25 EACH 2934990005 No No
((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- utical
methoxyphenyl)piperidine, hydrochloride) Analytical
Impurity
1A03060 Active Paroxol (25 mg) ((4R,3S)-4-(4-Fluorophenyl)-1- Pharmace Paroxetine F190P0 105812-81- N/A $600.00 IN Chemical UN3077 25 EACH 2933399095 VIAL No No
methyl-3-piperidinemethanol) utical Mesylate 5 Synthesis
Analytical
Impurity

Page 43
Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A01140 Active Pemetrexed Acid (25 mg) (4-(2-(2-amino-4-oxo- Pharmace Pemetrexe F173X0 137281-39- N/A $650.00 CN Chemical 25 EACH 2933599550 VIAL No No
4,7-dihydro-3H-pyrrolo[2,3-d]pyrimidin-5- utical d 1 Synthesis
yl)ethyl)benzoic acid) Analytical
Impurity
1A00630 Active Pemetrexed Acid N-Hydroxysuccinimide Ester (25 Pharmace Pemetrexe F171M0 204257-65- N/A $500.00 CN Chemical 25 EACH 2933599550 VIAL No No
mg) (2,5-dioxopyrrolidin-1-yl 4-(2-(2-amino-4-oxo- utical d 8 Synthesis
4,7-dihydro-3H-pyrrolo[2,3-d]pyrimidin-5- Analytical
yl)ethyl)benzoate) Impurity
1A00640 Active Pemetrexed Dimethyl Ester (25 mg) (dimethyl (4- Pharmace Pemetrexe F17260 155405-81- N/A $650.00 CN Chemical 25 EACH 2933599550 VIAL No No
(2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3- utical d 5 Synthesis
d]pyrimidin-5-yl)ethyl)benzoyl)-L-glutamate) Analytical
Impurity
1A00620 Active Pemetrexed Disodium Enantiomer (25 mg) ((2R)- Pharmace Pemetrexe F171L0 937370-10- N/A $650.00 CN Chemical 25 EACH 2933599550 VIAL No No
2-[[4-[2-(2-amino-4-oxo-4,7-dihydro-1H- utical d 0 Synthesis
pyrrolo[2,3-d]pyrimidin-5- Analytical
yl)ethyl]benzoyl]amino]pentanedioic acid, sodium Impurity
salt)
1A01150 Active Pemetrexed Glutamide Sodium (25 mg) ((S)-4- Pharmace Pemetrexe F177S0 144051-68- N/A $700.00 CN Chemical 25 EACH 2933599550 VIAL No No
((S)-4-(4-(2-(2-amino-4-oxo-4,7-dihydro-3H- utical d 3 (free acid) Synthesis
pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)-4- Analytical
carboxybutanamido)-4-carboxybutanoate, sodium Impurity
salt)
1A00610 Active Pemetrexed Glutamide Trisodium Salt (25 mg) Pharmace Pemetrexe F171K0 1265908- N/A $650.00 CN Chemical 25 EACH 2933599550 VIAL No No
(((S)-4-(4-(2-(2-amino-4-oxo-4,7-dihydro-1H- utical d 59-5 Synthesis
pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)-4- Analytical
carboxybutanoyl)-L-glutamic acid, sodium salt) Impurity
1A02360 Active Pemetrexed Sodium 1-Methyl Ester (25 mg) ((S)- Pharmace Pemetrexe F184R0 1265908- N/A $900.00 CN Chemical 25 EACH 2933599550 VIAL No No
4-(4-(2-(2-amino-4-oxo-4,7-dihydro-3H- utical d 61-9 Synthesis
pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)-5- Analytical
methoxy-5-oxopentanoic acid, sodium salt) Impurity
1A02370 Active Pemetrexed Sodium 5-Methyl Ester (25 mg) ((S)- Pharmace Pemetrexe F184S0 1265908- N/A $1,400.00 CN Chemical 25 EACH 2933599550 VIAL No No
2-(4-(2-(2-amino-4-oxo-4,7-dihydro-3H- utical d 60-8 Synthesis
pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)-5- Analytical
methoxy-5-oxopentanoic acid, sodium salt) Impurity
1A02230 Active Pemetrexed Tromethamide (25 mg) (N2-(4-(2-(2- Pharmace Pemetrexe F184Q0 N/A N/A $1,400.00 CN Chemical 25 EACH 2933599550 VIAL No No
amino-4-oxo-4,7-dihydro-3H-pyrrolo[2,3- utical d Synthesis

Page 44
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
d]pyrimidin-5-yl)ethyl)benzoyl)-N5-(1,3-dihydroxy- Analytical
2-(hydroxymethyl)propan-2-yl)-L-glutamine) Impurity
1A04690 Active Phenylethoxy Salmeterol (25 mg) (4-(1-hydroxy-2- Pharmace F207X0 94749-02-7 N/A $750.00 CN Chemical 25 EACH 2922504500 VIAL No No
((6-phenethoxyhexyl)amino)ethyl)-2- utical Synthesis
(hydroxymethyl)phenol) Analytical
Impurity
1A04700 Active Phenylpropoxy Salmeterol (25 mg) (4-(1-hydroxy- Pharmace F207E0 94749-11-8 N/A $1,500.00 CN Chemical 25 EACH 2922504500 VIAL No No
2-((6-(3-phenylpropoxy)hexyl)amino)ethyl)-2- utical Synthesis
(hydroxymethyl)phenol; 4-{1-Hydroxy-2-[6-(3- Analytical
phenylpropoxy)hexylamino]ethyl}-2- Impurity
(hydroxymethyl)phenol)
1A03070 Active Piperazinedionecarbonyl D-phenylglycylglycine Pharmace F194K0 2170771- N/A $1,300.00 IN Chemical 25 EACH 2933599550 VIAL No No
(25 mg) ((R)-(2-(4-ethyl-2,3-dioxopiperazine-1- utical 47-6 Synthesis
carboxamido)-2-phenylacetyl) glycine) Analytical
Impurity
1A00450 Active Pyrazinediethanol (10 mg) (2,2'-(pyrazine-2,5- Pharmace Clavulanat F16850 4744-51-8 N/A $300.00 CN Chemical 10 EACH 2933998350 VIAL No No
diyl)bis(ethan-1-ol)) utical e Synthesis
Analytical Potassium
Impurity
1A00380 Active Pyrazinediethanol Propionic Acid (5 mg) (3-(3,6- Pharmace Clavulanat F167X0 96681-85-5 N/A $1,200.00 CN Chemical 5 EACH 2933998350 VIAL No No
bis(2-hydroxyethyl)pyrazin-2-yl)propanoate, utical e (free acid) Synthesis
sodium salt) Analytical Potassium
Impurity
1A00460 Active Pyrrolic acid Derivative (10 mg) (4-(2- Pharmace Clavulanat F16860 404839-11- N/A $1,300.00 CN Chemical 10 EACH 2933999552 VIAL No No
hydroxyethyl)-1H-pyrrole-3-carboxylic acid) utical e 8 Synthesis
Analytical Potassium
Impurity
1A00190 Active Quetiapine Desethoxy (COLD SHIPMENT Pharmace Quetiapine R180C0 R165N0 329216-67- N/A $306.00 IN Chemical 25 EACH 2934990005 Cold Shipment VIAL No No
REQUIRED)(25 mg) (2-[4- utical fumarate 3 Synthesis Required
(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1- Analytical
yl]ethanol) Impurity
1A00130 Active Quetiapine Tetraethylene Glycol Fumarate Salt Pharmace Quetiapine F158K0 2470243- N/A $350.00 IN Chemical 25 EACH 2934990005 Cold Shipment VIAL No No
(COLD SHIPMENT REQUIRED) (2-(2-(2-(2-(4- utical fumarate 24-2 Synthesis Required
(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1- Analytical
yl)ethoxy)ethoxy)ethoxy)ethan-1-ol-fumarate) Impurity

Page 45
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A00140 Active R,R,S-Ezetimibe (25 mg) ((3R,4S)-1-(4- Pharmace Ezetimibe R187H0 F159N0 163380-16- N/A $675.00 CN Chemical 25 EACH 2933790002 VIAL No No
fluorophenyl)-3-((R)-3-(4-fluorophenyl)-3- utical 3 Synthesis
hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2- Analytical
one) Impurity
1A03610 Active R,R-Lamivudine (25 mg) (4-amino-1-((2R,5R)-2- Pharmace F20700 139757-68- N/A $1,780.00 CN Chemical 25 EACH 2934990005 VIAL No No
(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin- utical 9 Synthesis
2(1H)-one) Analytical
Impurity
1A00370 Active R-Levetiracetam Hydroxybutyramide Analog (10 Pharmace Levetiracet F170F0 1847568- N/A $450.00 CN Chemical 10 EACH 2924190002 VIAL No No
mg) ((R)-N-(1-amino-1-oxobutan-2-yl)-4- utical am 87-9 Synthesis
hydroxybutanamide) Analytical
Impurity
1A04760 Active Rac-Trans-4-Hydroxy Tolvaptan Pharmace Coming N/A N/A Coming EACH 2933998350 No No
utical Soon Soon
Analytical
Impurity
1A03810 Active Rifamycin O (25 mg) (4-O-(Carboxymethyl)-1- Pharmace F20590 14487-05-9 N/A $700.00 IN Chemical 25 EACH 2932999000 VIAL No No
deoxy-1,4-dihydro-4-hydroxy-1-oxo-rifamycin utical Synthesis
gamma-Lactone) Analytical
Impurity
1A00600 Active Risperidone Difluoroketone (10 mg) (3-(2-(4-(2,4- Pharmace Risperidon F167Q0 158697-67- N/A $350.00 CN Chemical 10 EACH 2933599550 VIAL No No
difluorobenzoyl)piperidin-1-yl)ethyl)-2-methyl- utical e 7 Synthesis
6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4- Analytical
one) Impurity
1A01160 Active Rivaroxaban Amine (25 mg) ((S)-4-(4-(5- Pharmace Rivaroxaba R201T0 F174P0 898543-06- N/A $770.00 CN Chemical 25 EACH 2934990005 VIAL No No
(aminomethyl)-2-oxooxazolidin-3- utical n 1 Synthesis
yl)phenyl)morpholin-3-one, hydrochloride) Analytical
Impurity
1A01470 Active Rivaroxaban Desmorpholinone Analog (25 mg) Pharmace Rivaroxaba F176Y0 936232-22- N/A $4,400.00 CN Chemical 25 EACH 2934990005 VIAL No No
((S)-5-chloro-N-((3-(4-((2- utical n 3 Synthesis
hydroxyethyl)amino)phenyl)-2-oxooxazolidin-5- Analytical
yl)methyl)thiophene-2-carboxamide) Impurity
1A01510 Active Rivaroxaban Desthiophene Analog (25 mg) ((R)-4- Pharmace Rivaroxaba F17730 1411775- N/A $1,100.00 CN Chemical 25 EACH 2934990005 VIAL No No
(4-(5-(aminomethyl)-2-oxooxazolidin-3- utical n 06-8 Synthesis
yl)phenyl)morpholin-3-one) Analytical
Impurity

Page 46
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A02250 Active Rivaroxaban Ethyl Carbamate (25 mg) (ethyl (4- Pharmace Rivaroxaba F182F0 1327778- N/A $1,400.00 CN Chemical 25 EACH 2934990005 VIAL No No
(3-oxomorpholino)phenyl)carbamate) utical n 39-1 Synthesis
Analytical
Impurity
1A02300 Active Rivaroxaban Ethylamino Analog (25 mg) (1- Pharmace Rivaroxaba F182L0 N/A N/A $2,000.00 CN Chemical 25 EACH 2934990005 VIAL No No
amino-3-((4-(3- utical n Synthesis
oxomorpholino)phenyl)amino)propan-2-yl 5- Analytical
chlorothiophene-2-carboxylate, hydrochloride) Impurity
1A01170 Active Rivaroxaban Glycolic Acid Analog (25 mg) ((S)-2- Pharmace Rivaroxaba F174Q0 931204-39- N/A $880.00 CN Chemical 25 EACH 2934990005 VIAL No No
(2-((4-(5-((5-chlorothiophene-2- utical n 6 Synthesis
carboxamido)methyl)-2-oxooxazolidin-3- Analytical
yl)phenyl)amino)ethoxy)acetic acid) Impurity
1A01190 Active Rivaroxaban N-acyl glycolic acid (25 mg) ((S)-2- Pharmace Rivaroxaba F173Y0 1151893- N/A $1,200.00 CN Chemical 25 EACH 2934990005 VIAL No No
(2-(5-chloro-N-(4-(5-((5-chlorothiophene-2- utical n 81-0 Synthesis
carboxamido)methyl)-2-oxooxazolidin-3- Analytical
yl)phenyl)thiophene-2-carboxamido)ethoxy)acetic Impurity
acid)
1A01520 Active Rivaroxaban N-methylphthalamido Analog (25 Pharmace Rivaroxaba F17740 2206360- N/A $1,210.00 CN Chemical 25 EACH 2934990005 VIAL No No
mg) ((S)-N1-methyl-N2-((2-oxo-3-(4-(3- utical n 74-7 Synthesis
oxomorpholino)phenyl)oxazolidin-5- Analytical
yl)methyl)phthalamide) Impurity
1A01460 Active Rivaroxaban Open Chain Dithiophene Analog (10 Pharmace Rivaroxaba F176X0 1807455- N/A $3,000.00 CN Chemical 10 EACH 2934990005 VIAL No No
mg) ((S)-5-chloro-N-(4-(5-((5-chlorothiophene-2- utical n 76-0 Synthesis
carboxamido)methyl)-2-oxooxazolidin-3- Analytical
yl)phenyl)-N-(2-(2-(methylamino)-2- Impurity
oxoethoxy)ethyl)thiophene-2-carboxamide)
1A02240 Active Rivaroxaban Open Oxomorpholine Ring (10 mg) Pharmace Rivaroxaba F182E0 1160170- N/A $3,000.00 CN Chemical 10 EACH 2934990005 VIAL No No
((S)-5-chloro-N-((3-(4-(2-hydroxy-N-(2- utical n 00-2 Synthesis
hydroxyethyl)acetamido) phenyl)-2-oxooxazolidin- Analytical
5-yl)methyl)thiophene-2-carboxamide) Impurity
1A00670 Active Rivaroxaban Open Ring (10 mg) ((R)-5-chloro-N- Pharmace Rivaroxaba F171C0 721401-53- N/A $400.00 CN Chemical 10 EACH 2934990005 VIAL No No
(2-hydroxy-3-((4-(3- utical n 2 Synthesis
oxomorpholino)phenyl)amino)propyl)thiophene-2- Analytical
carboxamide) Impurity
1A00650 Active Rivaroxaban Open Ring Methylamine (10 mg) Pharmace Rivaroxaba F170K0 2459303- N/A $1,500.00 CN Chemical 10 EACH 2934990005 VIAL No No
((S)-4-(4-((2-hydroxy-3- utical n 14-9 Synthesis

Page 47
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
(methylamino)propyl)amino)phenyl)morpholin-3- Analytical
one) Impurity
1A01550 Active Rivaroxaban Open Ring S-isomer (25 mg) ((S)-5- Pharmace Rivaroxaba F177F0 1325210- N/A $2,900.00 CN Chemical 25 EACH 2934990005 VIAL No No
chloro-N-(2-hydroxy-3-((4-(3- utical n 62-5 Synthesis
oxomorpholino)phenyl)amino)propyl)thiophene-2- Analytical
carboxamide) Impurity
1A00660 Active Rivaroxaban Phthalamide (25 mg) (N1,N2- Pharmace Rivaroxaba F170L0 1365267- N/A $680.00 CN Chemical 25 EACH 2934990005 VIAL No No
bis(((S)-2-oxo-3-(4-(3- utical n 36-2 Synthesis
oxomorpholino)phenyl)oxazolidin-5- Analytical
yl)methyl)phthalamide) Impurity
1A02270 Active Rivaroxaban Phthalimide (25 mg) ((S)-2-(2- Pharmace Rivaroxaba F182H0 1369969- N/A $770.00 CN Chemical 25 EACH 2934990005 VIAL No No
hydroxy-3-((4-(3- utical n 44-7 Synthesis
oxomorpholino)phenyl)amino)propyl)isoindoline- Analytical
1,3-dione) Impurity
1A01570 Active Rivaroxaban Phthalimido Analog (25 mg) ((R)-2- Pharmace Rivaroxaba F17780 446292-07- N/A $880.00 CN Chemical 25 EACH 2934990005 VIAL No No
(2-hydroxy-3-((4-(3- utical n 5 Synthesis
oxomorpholino)phenyl)amino)propyl) isoindoline- Analytical
1,3-dione) Impurity
1A02280 Active Rivaroxaban isomer (25 mg) (4-(4-(((2-(5- Pharmace Rivaroxaba F182J0 2310316- N/A $2,400.00 CN Chemical 25 EACH 2934990005 VIAL No No
chlorothiophen-2-yl)-4,5-dihydrooxazol-5- utical n 95-9 Synthesis
yl)methyl)amino)phenyl)morpholin-3-one) Analytical
Impurity
1A02290 Active Rivaroxaban phthalimido ethyl ester analog (25 Pharmace Rivaroxaba F182K0 2206826- N/A $2,600.00 CN Chemical 25 EACH 2934990005 VIAL No No
mg) ((S)-1-(1,3-dioxoisoindolin-2-yl)-3- utical n 56-2 Synthesis
((ethoxycarbonyl)(4-(3- Analytical
oxomorpholino)phenyl)amino)propan-2-yl 5- Impurity
chlorothiophene-2-carboxylate)
1A00170 Active Rosuvastatin Isoamyl Ester (25 mg) ((3S,5R,6E)- Pharmace Rosuvastati F158U0 1197348- N/A $695.00 IN Chemical 25 EACH 2935909550 VIAL No No
7-[4-(4-flurophenyl)-6-(1-methylethyl)-2-[N- utical n Calcium 98-3 Synthesis
methyl(methylsulphonyl)amino]-5-pyrimidinyI]-3,5- Analytical
dihydroxy-6-heptanoic acid, methyl butyl ester) Impurity
1A00050 Active Rosuvastatin Ketone (25mg) ((R,E)-7-(4-(4- Pharmace Rosuvastati R192P0 R18110 1422619- N/A $795.00 CN Chemical 25 EACH 2935909550 VIAL No No
fluorophenyl)-6-isopropyl-2-(N- utical n Calcium 13-3 Synthesis
methylmethylsulfonamido)pyrimidin-5-yl)-3- Analytical
hydroxy-5-oxohept-6-enoic acid) Impurity

Page 48
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A01200 Active Rosuvastatin Lactone (25 mg) (N-[4-(4- Pharmace Rosuvastati R190Q0 F178K0 503610-43- N/A $770.00 IN Chemical 25 EACH 2935909550 VIAL No No
Fluorophenyl)-5-{(E)-2-[(2S,4R)-4-hydroxy-6- utical n Calcium 3 Synthesis
oxotetrahydro-2H-pyran-2-yl]vinyl}-6- Analytical
isopropylpyrimidin-2-yl]-N- Impurity
methylmethanesulfonamide)
1A00440 Active S-Levetiracetam Hydroxybutyramide Analog (10 Pharmace Levetiracet F170G0 1868118- N/A $450.00 CN Chemical 10 EACH 2924190002 VIAL No No
mg) ((S)-N-(1-amino-1-oxobutan-2-yl)-4- utical am 63-1 Synthesis
hydroxybutanamide) Analytical
Impurity
1A02620 Active Sitagliptin (R)-Triazecine Analog (25 mg) ((R)-10- Pharmace Sitagliptin F18810 2088771- N/A $1,500.00 IN Chemical 25 EACH 2933998350 VIAL No No
(2,4,5-trifluorobenzyl)-3-(trifluoromethyl)- utical 61-1 Synthesis
6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4- Analytical
c][1,4,7]triazecine-8,12(5H,9H)-dione) Impurity
1A02840 Active Sitagliptin Acid (25 mg) ((R)-3-Amino-4-(2,4,5- Pharmace Sitagliptin F19550 936630-57- N/A $900.00 IN Chemical 25 EACH 2922493800 VIAL No No
trifluorophenyl)butanoic acid) utical 8 Synthesis
Analytical
Impurity
1A02660 Active Sitagliptin Alcohol (25 mg) (3-hydroxy-1-(3- Pharmace Sitagliptin F18840 1253056- N/A $550.00 IN Chemical 25 EACH 2933599550 VIAL No No
(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3- utical 01-7 Synthesis
a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan- Analytical
1-one) Impurity
1A02650 Active Sitagliptin Enamine (25 mg) ((Z)-3-amino-1-(3- Pharmace Sitagliptin F18720 767340-03- N/A $700.00 IN Chemical 25 EACH 2933599550 VIAL No No
(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3- utical 4 Synthesis
a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)but-2- Analytical
en-1-one) Impurity
1A02670 Active Sitagliptin Ketone (25 mg) (1-(3-(trifluoromethyl)- Pharmace Sitagliptin F18850 764667-65- N/A $300.00 IN Chemical 25 EACH 2933599550 VIAL No No
5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)- utical 4 Synthesis
4-(2,4,5-trifluorophenyl)butane-1,3-dione) Analytical
Impurity
1A02600 Active Sitagliptin Phenylcrotonyl Analog (25 mg) ((E)-1- Pharmace Sitagliptin F18950 1253056- N/A $1,200.00 25 EACH 2933599550 No No
{3-(Trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3- utical 18-6
a]pyrazin-7(8H)-yl}-4-(2,4,5-trifluorophenyl)but-2- Analytical
en-1-one) Impurity
1A02610 Active Sitagliptin Styrylacetyl Analog (25 mg) ((E)-1-(3- Pharmace Sitagliptin R210G0 F18510 1803026- N/A $750.00 CN Chemical 25 EACH 2933599550 VIAL No No
(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3- utical 58-5 Synthesis
a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)but-3- Analytical

Page 49
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
en-1-one) Impurity
1A04290 Active Sodium 4-Hydroxy-N-methylleucinate (25 mg) (4- Pharmace F209J0 N/A N/A $2,200.00 CN Chemical 25 EACH 2922505000 VIAL No No
hydroxy-4-methyl-2-(methylamino)pentanoic acid, utical Synthesis
sodium salt) Analytical
Impurity
1A04310 Active Sugammadex Sodium Sulfone (10 mg) Pharmace F20400 N/A N/A $1,100.00 CN Chemical 10 EACH 2932999000 VIAL No No
(6A,6B,6C,6D,6E,6F,6G,6H-octadeoxy- utical Synthesis
6A,6B,6C,6D,6E,6F,6G,6H-octaki-gamma- Analytical
Cyclodextrin, sodium salt) Impurity
1A04560 Active Sugammadex Sodium Sulfoxide (10 mg) Pharmace F205R0 1202259- N/A $1,500.00 CN Chemical 10 EACH 2932999000 VIAL No No
(6A,6B,6C,6D,6E,6F,6G,6H-octadeoxy- utical 85-5 Synthesis
6A,6B,6C,6D,6E,6F,6G,6H-octakis[(2- Analytical
carboxyethyl)sulfinyl]-gamma-Cyclodextrin, Impurity
sodium salt)
1A05050 Active Sunitinib N-Oxide (25 mg) ((Z)-N,N-diethyl-2-(5- Pharmace Coming 356068-99- N/A Coming 25 EACH 2933790002 No No
((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4- utical Soon 0 Soon
dimethyl-1H-pyrrole-3-carboxamido)ethan-1- Analytical
amine oxide) Impurity
1A01290 Active TEMED Dihydrochloride (25 mg) (N1,N1,N2,N2- Pharmace Clavulanat F17500 7677-21-6 N/A $700.00 CN Chemical 25 EACH 2921290055 VIAL No No
tetramethylethane-1,2-diamine, hydrochloride) utical e Synthesis
Analytical Potassium
Impurity
1A01930 Active Tacrolimus 5E-ene (25 mg) Pharmace Tacrolimus F182Y0 104987-16- N/A $1,600.00 CN Chemical 25 EACH 2934990005 VIAL No No
utical 8 Synthesis
Analytical
Impurity
1A04320 Active Tenofovir Soproxil (((((((R)-1-(6-amino-9H-purin-9- Pharmace F203V0 211364-69- N/A $1,200.00 CN Chemical 25 EACH 2933599550 VIAL No No
yl)propan-2- utical 1 Synthesis
yl)oxy)methyl)(hydroxy)phosphoryl)oxy)methyl Analytical
isopropyl carbonate) (25 mg) Impurity
1A01850 Active Tetrahydrothienopyridine Hydrochloride (25 mg) Pharmace Clopidogrel F178N0 28783-41-7 N/A $400.00 CN Chemical 25 EACH 2934990005 VIAL No No
(4,5,6,7-Tetrahydrothieno[3,2-c]pyridine, utical Bisulfate Synthesis
hydrochloride) Analytical
Impurity
1A00400 Active Tetramethyl Ethylene Diamine (25 mg) Pharmace Clavulanat F16800 110-18-9 N/A $1,300.00 CN Chemical UN2372 25 EACH 2921290055 AMPULE No No

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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
(N1,N1,N2,N2-tetramethylethane-1,2-diamine) utical e Synthesis
Analytical Potassium
Impurity
1A02680 Active Thiazolylacetyl Glycine Oxime Acetal Pharmace Cefdinir Coming 178422-40- N/A Coming EACH 2934100000 No No
utical Soon 7 Soon
Analytical
Impurity
1A04640 Active Ticabesone Furoate Pharmace Coming 397864-58- N/A Coming EACH 2932190002 No No
utical Soon 3 Soon
Analytical
Impurity
1A01440 Active Ticlopidine Pyridinium Analog (25 mg) (5-(2- Pharmace Clopidogrel F177U0 53885-64-6 N/A $900.00 CN Chemical 25 EACH 2934990005 VIAL No No
chlorobenzyl)thieno[3,2-c]pyridin-5-ium, chloride) utical Bisulfate Synthesis
Analytical
Impurity
1A01690 Active Ticlopidine Pyridinium Bromide Analog (25 mg) (5- Pharmace Clopidogrel F177E0 2418591- N/A $1,500.00 CN Chemical 25 EACH 2934990005 VIAL No No
(2-chlorobenzyl)-6,7-dihydrothieno[3,2-c]pyridin-5- utical Bisulfate 13-4 Synthesis
ium, bromide) Analytical
Impurity
1A03890 Active Tofacitinib Amide (25 mg) Pharmace Coming 1675248- N/A Coming 25 EACH 2933599550 No No
utical Soon 19-7 Soon
Analytical
Impurity
1A01620 Active Tolterodine Dimer (25 mg) (2,2'- Pharmace Tolterodine F177C0 854306-72- N/A $1,600.00 CN Chemical 25 EACH 2922299000 VIAL No No
((isopropylazanediyl)bis(1-phenylpropane-3,1- utical tartrate 2 Synthesis
diyl))bis(4-methylphenol); N,N-Bis[3-(2-hydroxy-5- Analytical
methylphenyl)-3-phenylpropyl]-N-isopropylamine) Impurity
1A01680 Active Tolterodine Propanol Analog (25 mg) (2-(3- Pharmace Tolterodine F17800 851789-43- N/A $1,800.00 IN Chemical 25 EACH 2907290500 VIAL No No
Hydroxy-1-phenylpropyl)-4-methylphenol) utical tartrate 0 Synthesis
Analytical
Impurity
1A04730 Active Tolvaptan Open Ring Hydroxyacid (25 mg) (4-(5- Pharmace F20840 1346599- N/A $3,200.00 IN Chemical 25 EACH 2924296000 VIAL No No
chloro-2-(2-methyl-4-(2- utical 75-4 Synthesis
methylbenzamido)benzamido)phenyl)-4- Analytical
hydroxybutanoic acid) Impurity

Page 51
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A04720 Active Tolvaptan Open Ring Ketoacid (25 mg) (4-(5- Pharmace F20830 1346599- N/A $2,000.00 IN Chemical 25 EACH 2924296000 VIAL No No
chloro-2-(2-methyl-4-(2- utical 56-1 Synthesis
methylbenzamido)benzamido)phenyl)-4- Analytical
oxobutanoic acid) Impurity
1A04750 Active Tolvaptan S-Enantiomer (10 mg) ((S)-N-(4-(7- Pharmace F208C0 331947-44- N/A $2,100.00 CN Chemical 10 EACH 2933998350 VIAL No No
chloro-5-hydroxy-2,3,4,5-tetrahydro-1H- utical 5 Synthesis
benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2- Analytical
methylbenzamide) Impurity
1A00750 Active Tolyloyl Bromopropionamide (25 mg) (3-bromo- Pharmace Zolpidem F172A0 836627-56- N/A $770.00 CN Chemical 25 EACH 2924296000 VIAL No No
N,N-dimethyl-4-oxo-4-(p-tolyl)butanamide) utical Tartrate 6 Synthesis
Analytical
Impurity
1A01630 Active Tolyloyl Propionamide (25 mg) (N,N-Dimethyl-4- Pharmace Zolpidem F177V0 402470-91- N/A $770.00 IN Chemical 25 EACH 2924296000 VIAL No No
oxo-4-(p-tolyl)butanamide) utical Tartrate 1 Synthesis
Analytical
Impurity
1A01640 Active Tolyloyl Propionic Acid (25 mg) (4-Oxo-4-(p- Pharmace Zolpidem F177W0 4619-20-9 N/A $770.00 IN Chemical 25 EACH 2918300000 VIAL No No
tolyl)butanoic Acid) utical Tartrate Synthesis
Analytical
Impurity
1A01820 Active Ureidolacosamide (25 mg) ((R)-N-Benzyl-2-(3- Pharmace Lacosamid F17860 2295925- N/A $1,900.00 IN Chemical 25 EACH 2924296000 VIAL No No
benzylureido)-3-methoxypropanamide) utical e 90-3 Synthesis
Analytical
Impurity
1A03370 Active Varenicline Acetamide (25 mg) (COLD Pharmace F200T0 1213781- N/A $1,175.00 CN Chemical 25 EACH 2933998350 VIAL No No
SHIPMENT REQUIRED) (1-(6,7,9,10-tetrahydro- utical 59-9 Synthesis
8H-6,10-methanoazepino[4,5-g]quinoxalin-8- Analytical
yl)ethan-1-one) Impurity
1A03340 Active Varenicline Formamide (25 mg) (6,7,9,10- Pharmace F199N0 796865-82- N/A $1,850.00 CN Chemical 25 EACH 2933998350 VIAL No No
tetrahydro-8H-6,10-methanoazepino[4,5- utical 2 Synthesis
g]quinoxaline-8-carbaldehyde) Analytical
Impurity
1A03820 Active Vilanterol Desethylene Homolog Triphenylacetate Pharmace F20420 N/A N/A $1,500.00 CN Chemical 25 EACH 2922504500 VIAL No No
(25 mg) ((R)-4-(2-((6-((2,6- utical Synthesis
dichlorobenzyl)oxy)hexyl)amino)-1-hydroxyethyl)- Analytical
2-(hydroxymethyl)phenol, 2,2,2-triphenylacetate) Impurity

Page 52
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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
1A03910 Active Vilanterol Diamine Triphenylacetate (25 mg) (4,4'- Pharmace F20610 N/A N/A $1,650.00 CN Chemical 25 EACH 2922504500 VIAL No No
((1R,1'R)-((oxybis(hexane-6,1- utical Synthesis
diyl))bis(azanediyl))bis(1-hydroxyethane-2,1- Analytical
diyl))bis(2-(hydroxymethyl)phenol), 2,2,2- Impurity
triphenylacetate))
1A03860 Active Vilanterol Trifenatate Dioxin (50 mg) ((alphaR)- Pharmace F203X0 2677047- N/A $1,300.00 CN Chemical 50 EACH 2932996560 VIAL No No
alpha-[[[6-[2-[(2,6- Dichlorophenyl)methoxy] utical 63-9 Synthesis
ethoxy]hexyl] amino]methyl]-2,2-dimethyl-4H-1,3- Analytical
benzodioxin-6-methanol, triphenylacetate) Impurity
1A03850 Active Vilanterol Trifenatate S-Enantiomer (25 mg) ((S)- Pharmace F205L0 N/A N/A $1,950.00 IN Chemical 25 EACH 2922504500 VIAL No No
4-(2-((6-(2-((2,6- utical Synthesis
dichlorobenzyl)oxy)ethoxy)hexyl)amino)-1- Analytical
hydroxyethyl)-2-(hydroxymethyl)phenol 2,2,2- Impurity
triphenylacetate)
1A04950 Active cis-Lurasidone Hydrochloride (25 mg) (rel- Pharmace F209W0 139563-25- N/A $1,250.00 CN Chemical 25 EACH 2934200000 VIAL No No
(3aR,4S,7R,7aS)-2-(((1R,2S)-2-((4- utical 0 Synthesis
(benzo[d]isothiazol-3-yl)piperazin-1- Analytical
yl)methyl)cyclohexyl)methyl)hexahydro-1H-4,7- Impurity
methanoisoindole-1,3(2H)-dione, hydrochloride)
1A04960 Active endo-Lurasidone (25 mg) ((3aR,4R,7S,7aS)-2- Pharmace F209X0 1318074- N/A $795.00 IN Chemical 25 EACH 2934200000 VIAL No No
{[1R,2R]-2-[4-(1,2-benzisothiazol-3-yl)-piperazin-1- utical 25-7 Synthesis
yl-methyl]-cyclohexyl methyl}hexahydro-4,7- Analytical
methano-2H-isoindole-1,3-dione) Impurity
1A00240 Active o-Celecoxib (25mg) (4-(5-(o-tolyl)-3- Pharmace Celecoxib F159P0 170569-99- N/A $300.00 CN Chemical 25 EACH 2935909550 VIAL No No
(trifluoromethyl)-1H-pyrazol-1- utical 0 Synthesis
yl)benzenesulfonamide) Analytical
Impurity
1A02330 Active rac-4,5-Dehydropregabalin (25 mg) (3- Pharmace Pregabalin F18420 216576-74- N/A $800.00 IN Chemical 25 EACH 2922498050 VIAL No No
(aminomethyl)-5-methylhex-4-enoic acid) utical 8 Synthesis
Analytical
Impurity
1A02350 Active rac-5,6-Dehydropregabalin (25 mg) (3- Pharmace Pregabalin F182M0 1136478- N/A $2,000.00 CN Chemical 25 EACH 2922498050 VIAL No No
(aminomethyl)-5-methylhex-5-enoic acid) utical 30-2 Synthesis
Analytical
Impurity
1A02110 Active rac-Clopidogrel Acid N-Oxide (25 mg) (5- Pharmace Clopidogrel F182A0 N/A N/A $1,200.00 CN Chemical 25 EACH 2934990005 VIAL No No

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USP Pharmaceutical Analytical Impurities Catalog


Catalog # Status Product Name Product Associate Current Previous CAS# NDC# Unit Price Co. of Material Origin UN # Net Weight Unit Of Commodity Special Pkg. Type USMCA KORUS Base Base Control
Type d Drug Lot Lot (Valid Origin Measure Codes (HS Restriction Eligible Eligible Control Drug %
Substance Use Date) Codes)* Drug
(carboxy(2-chlorophenyl)methyl)-4,5,6,7- utical Bisulfate Synthesis
tetrahydrothieno[3,2-c]pyridine 5-oxide) Analytical
Impurity
1A02180 Active rac-Duloxetine-d7 Maleate (25 mg) (N-methyl-3- Pharmace Duloxetine F184N0 N/A N/A $1,650.00 CN Chemical 25 EACH 2845900100 VIAL No No
((naphthalen-1-yl-d7)oxy)-3-(thiophen-2-yl)propan- utical Synthesis
1-amine, maleate) Analytical
Impurity
1A02380 Active rac-Pregabalin Imide Dimer Amide (25 mg) (3-((3- Pharmace Pregabalin F197R0 1486961- N/A $2,000.00 IN Chemical 25 EACH 2925190100 VIAL No No
(aminomethyl)-5-methylhexanamido)methyl)-5- utical 58-3 Synthesis
methylhexanoic acid) Analytical
Impurity
1A02640 Active rac-Sitagliptin Hydrochloride (25 mg) (3-amino-1- Pharmace Sitagliptin F18830 2309520- N/A $400.00 IN Chemical 25 EACH 2933599550 VIAL No No
(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3- utical 11-2 Synthesis
a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan- Analytical
1-one hydrochloride) Impurity
1A04810 Active tert-Butyl ((1R,2R,5S)-2-amino-5- Pharmace Coming 1928729- N/A Coming EACH 2924299500 No No
(dimethylcarbamoyl)cyclohexyl)carbamate oxalate utical Soon 31-0 Soon
Analytical
Impurity
1A04800 Active tert-Butyl ((1S,2R,5S)-2-amino-5- Pharmace Coming 2703724- N/A Coming EACH 2924299500 No No
(dimethylcarbamoyl)cyclohexyl)carbamate oxalate utical Soon 30-3 Soon
Analytical
Impurity
1A01310 Active tert-Octylamine (25 mg) (2,4,4-trimethylpentan-2- Pharmace Clavulanat F175Q0 107-45-9 N/A $770.00 CN Chemical UN2734 25 EACH 2921196190 AMPULE No No
amine) utical e Synthesis
Analytical Potassium
Impurity
1A02060 Active trans-Cholecalciferol (25 mg) (COLD SHIPMENT Pharmace Cholecalcif F183Y0 22350-41-0 N/A $800.00 IN Chemical 25 EACH 2906195000 Cold Shipment VIAL No No
REQUIRED) utical erol Synthesis Required
Analytical
Impurity
VUD: Valid Use Date Co. of origin: Country of Origin UN#: UN Number Pkg. Type: Container Type RS Name: Description

* Disclaimer:
The Commodity Codes (HS codes) provided in this catalog are for information purposes only and are subject to change without notice. The exporter and/or importer of record is responsible for

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Last Updated On: September 27, 2023

USP Pharmaceutical Analytical Impurities Catalog

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