Vlt'*tlf,"f, L,^&tsCItsATo8rfl S

(A Division of Arch Pharmalabs Limit€d)

Foclory: Vllloge Polhrerl, Bllospur. Tquru Rood. Dlrl. Gurugrom, Horyono - lZl 413, lndlo
rel.: +?l-12'l.3sol42ll422/ 23. (M) log2l1u6s, web3lte: www.orchphormolobl.com

CERTIFICATE OF ANALYSIS
No: I /2
Product Name: Atorvastatin Calcium USP
Product Code 14000914 Inspection Lot No. 04000021 7380
Batch No. 314220010t Batch Size 91.800 KG
Manufacturing Date Mar,2022 Expiry Date Feb,2027

Sr.No Tests Results Specification

1 Description White crystalline powder White to off white
crystalline powder
2 Solubility Freely soluble in methanol, Soluble to freely soluble in
slightly soluble in alcohol, methanol, slightly soluble in
very slightly soluble in alcohol, insoluble to very
distilled water ,in pH 7.4 slightly soluble in distilled
phosphate buffer, and in water, in pH 7.4 phosphate
Acetonitrile; and insoluble buffer, and in Acetonitrile;
in aqueous solution of pH 4. insoluble in aqueous solution
of pH 4 and below.
J Identification
A. By IR Complies The Infrared absorption
spectrum of a potassium
bromide dispersion of the
sample must be concordant
with that of Atorvastatin
Calcium crystalline USP
reference /working standard.
B.By Calcium Complies The sample solution exhibits
a significant absorption at the
calcium emission line at
422.7 nm.
4 Water (%wlw) (Method Ia) 4.2 Yo wlw 3.5%owlw to 5.5% w/w
5 Enantiomeric purity (by HPLC) (% wlw) Not detected Not more than 0.3% ilw
(Atorvastatin related compound E)
6 Organic Impurities ( Procedure-2) (% w/w) (By HPLC)
Atorvastatin diamino 0.02 % (BDL) Not more than 0.15% ilw
Atorvastatin Related Compound A 0.03 % (BDL) Not more than 0.3% ilw
Atorvastatin Related Compound B 0.0r % (BDL) Not more than 0.3% w/w
Atorvastatin Related Compound C Not detected Not more than 0.3% w/w
VERIFIED BY APPROVED BY

.168 Dq' Lo?-7

(1
*9-f9l 7
(HOD-QC/DESTGNEE) (HOD-QA/ D ESIGNEE)

Issue Datez 25.09.2023

Format No.:CQAO 45 lF 02-03

Corp. Ofice:503/505, Hyde pork, Sqkl Vlhor toqd, Opp. Anto lndurhlql
Eslole, Andherl (E), Mumbol . 400 072, tndtq
lel: +?1-212-42871210 Fox +91 -22 - 4287 1 285, Webslte : www,.orchphormoiobs.com
 VlrynruF"E lLeBotserorufls
(A Division of Arch pharmalabs Ltmited)
Foclory: vllloge Pothred, Bllospur - rouru Roqd, Dlrl. Gurugrom, Horyono - 122 413, Indlo
re].: +?l-124-3581421/1fr1423. (M) loozll4/,6s,webclte: www.orchphormqlobs.com

CERTIFICATE OF ANALYSIS
No:212
Product Name: Atorvastatin Calcium USP
Product Code 14000914 Inspection Lot No. 0400002 1 7380
Batch No. 3142200t01 Batch Size 91.800 KG
Manufacturing Date I|v4ar,2022 Expiry Date Feb,2027

Sr.No Tests Results Specification

Atorvastatin 3-deoxy-hept-2-enoic acid 0.0r % (BDL) Not more than 0.10% w/w
Atorvastatin Related Compound H 0.03% (BDL) Not more than 0.15% w/w
Atorvastatin epoxy tetra hydro furan Not detected Not more than 0.15o/o wlw
analog
Atorvastatin ethyl ester Not detected Not more than 0.15olo w/w
Atorvastatin Related Compound D 0.01% (BDL) Not more than 0.l5Yowlw
Atorvastatin Related Compound I Not detected Not more than 0.15o/ow/w
Any other individual impurity 0.05% Not more than 0.ljYo wlw
Total Impurities 0.t0% Not more than I .0%owlw
7 Assay (By HPLC) (% wlw on anhydrous 100.8 % w/w 98.0% vv/w to l02.0Yo wlw
and solvent free basis)
8 Residual solvents (By GC-HS) (ppm)
Methanol Not detected Not more than 500 ppm
Ethyl acetate Not detected Not more than 2000 ppm
Methylene chloride Not detected Not more than 500 ppm
Tert-Butyl methyl ether (MTBE) 594 ppm Not more than 1500 ppm
Cyclohexane Not detected Not more than 700 ppm
Iso-propanol Not detected Not more than 700 ppm
Acetone Not detected Not more than 500 ppm
Tert-Butanol Not detected Not more than 100 ppm
Pivalic acid Not detected Not more than 100 ppm
Acetic Acid 33 ppm Not more than 1000 ppm
Additional Test :As per customer requirement
9 Particle size (By Malvern Mastersizer)
D(10) 0.52 pm NMT 5 pm
D(50) 3.36 pm NMT l0 pm
D(e0) 7.63 p,m NMT 20 pm
Remarks: Material Complies as per above specifications. (D.C.No. FP/SPS/079-14)
BDL: Below Disregard Limit

VERIF'IED BY APPROVED BY

,y\A 2nu9 ? {-
aQ- LD
4.i
(HOD-QC/DESTGNEE) (HOD-QA/ DESTGNEE)

Issue Date:.25.09.2023
Format No.:CQAO 45 lF 02-03

Corp. Ofrce :503/505, Hyde Pod<, Sskl Vlhq Rood, Opp. Anso lndurtrtol Ertqle, Andhed (E), Mumbol -
400 072, Indlq
leli +91'A2-12871210 tox +?1-2it-428712E5, Webdte : www.orchphormolqbc.com