ANUH PHARMA LTD. CERTIFICATE OF ANALYSIS Product Name Clobetasol Propionate USP Micronised Sample Qty. [+] 1X 5.0 gm | Batch No ‘APL/02340/1-19 ‘AR. No. + | AFP/318/2019 Mfg. Date 0972019 “Exp.Date__| : | 08/2024 Sr. | Test ‘Observation Limit “| No. _ _ I_| Description “A wihite to cream, crystalline powder. | A white to cream, crystalline powder. 2 | Solubility Practically insoluble in water; slightly soluble in benzene and in diethyl ether; sparingly soluble in ethanol; soluble in acetone in dimethyl sulfoxide, in chloroform, in methanol & in dioxane. Practically insoluble in water; slightly soluble in benzene and in diethyl ether; sparingly soluble in ethanol; soluble in acetone in dimethyl sulfoxide, in chloroform, in methanol & in dioxane. Identification Test ~A-by Infra Red ‘Complies Infrared spectrum obtained with sample is concordant with reference spectrum of Clobetasol Propionate ws 4_| Melting range i98C ‘About 196°C 5 | Specific optical rotation +100.00" +98" to +104". | (on dried basis) : ©_| Loss on drying 017% ‘Not more than 2.0% 7_| Residue on ignition 0.07% ‘Not more than 0.1% ~ '8_| Heavy metals “Complies Not more than 20 ppm. 9. | Organic Impurities i) Any individual impurity 063% ‘Not more than 1.0% |__ fii) Total impurities 0.85% - Not more than 2.5% 10 | Assay (on dried basis) 99.45% Not less than 97.0% & not more than les 102.0% 11 | Residual solvents ‘Methylene chloride ND. ‘Not more than 600 ppm i ‘Acetone ND. = ‘Not more than 5000 ppm - Ethyl Acetate ND. ‘Not more than 5000 ppm Methanol 561.41 ppm ‘Not more than 3000 ppm. | Pyridine ND. ‘Not more than 200 ppm |__[pmr ND. - ‘Not more than 880 ppm ‘Additional test 1 | Particle size ‘<15 microns, ‘Complies [90.0% “Remarks: The sample eomplies/ de ply as per Specification T-FP-09 (USP). For Anuh Pharma Ltd. ahh ar Authorized Signatory. Office: 3-A Shivsagar Estate, North Wing, Dr. Annie Besant Road, Worl, Mumbai 400 018. India, Tels +91-22-6622 7575 Fi CIN : L24230MH1960PLCO11586 Wo Serve Since 1992 ++91-22-6622 7600 (7500 Email: anuh@sk1932.com Us. Great Pacific Exports Pvt, Ltd, Plot No. 0-5/8 & 6/9, 7.7.C. Industrial Area, Turbhe | 400 703, indiaANUH PHARMA LTD. CERTIFICATE OF ANALYSIS Product Name |: | Clobetasol Propionate USP Micronised | Sample Qty. |: [1X 5.0 gm Bateh No + [APL/O1228/1-19 AR. No. ‘AFP/227/2019 Mfg. Date 09/2019 Exp. Date |: | 08/2024 Ss Test Observation Limit 1 “Aimod! white, enatalline powder, | A white o cream, enstalline powder Practically insoluble in water, 5 soluble in waters | practically insoluble in water slightly soluble in Shy soluble in benzene and it | pzene and in dehy ether, sparingly soluble 2 ‘| Solubility licthyl ether; sparingly soluble in |; ethanol; soluble in acetone in dimethyl ethanol; soluble in acetone in| in tnanel, solible in aes ol Eh methyl sulfoxide, in ehlorofom, | SHESGe, im ehloroform, in methanol & in 7 in methanol & in dioxane K _ 3_| Hentiieation Tnfrared spectrum obtained with sample is “Test ~Acby Infra Red Complies concordant’ with reference spectum of = 7 Clobetasol Propionate WS. | Assay (om dried basis) 371% [Not iss than 97.0% & Not mors than 102.0% 5 _| Residue on ignition 007% ‘Not more than 0.1% | | Heavy metals Complies "Not more than 20 ppm z Organic Impurities, 1 [iyAny individual impurity [085% Not more than 10% i) Total impurities 1.0% ‘Not more than 2.5% | Melting range is?C ——TFAbout 196°C Specific optical rotation ar on 9 (on dried basis) 100.07" +98" to +104" TO [Loss on drying ose ‘Nat more than 20% Residual solvents a ‘Methylene chloride ND. ‘Nat more than 600 ppm Acetone To: "Not more than 5000 ppm 11 [Bihyl Acetate ND. — ‘Not more than 5000 ppm ‘Methanol 413.03 ppm "Not more than 3000-ppm. Pyridine Ni : "Not more than 200 ppm DME is "Not more than 880 ppm ‘Additional Test | 1 [2amlile Size “< 15 Mierons: [Compt [50.03% — Femara: Te sample complies dosenokeomply as por Specification TFP-09 (USP) We Serve Since 1932 For Anuh Pharma Ltd. rat Pete oe Authorized Signatory. Office: 3-A Shivsagar Estate, North Wing, Dr. Annie Besant Road, Worl, Mumbai 400 018. India, Tol: +91-22-6622 7575 CIN : L24230MH 1960PLCO11586 Fax: +91-22-6622 7600 /7500 Email: anuh@sk1932.com Factory : Mis. Great Pacific Exports Pu. Lid., Plot No. D-5/8 & 5/9, TTC. Industrial Area, Turbhe Navi Mumbai- 400 703, india,AANNUH PHARMA LTD. CERTIFICATE OF ANALYSIS Product Name ‘Clobetasol Propionate USP Micronized ‘Sample Qty. | 1x5.0 gm Batch No APLIOI3AVA-19 ‘AR.No. [2 | AFPA2572019 Mfg. Date | 122019 Exp.Date [+] 11/2024 eB Test Observation Limit 1 _| Description | A white, aystalline powder. ‘A white to cream, crystalline powder. 2 | Solubility Practically insoluble in water; Practically insoluble in water; slightly slightly soluble in benzene and in _| soluble in benzene and in diethylether, diethylether; sparingly soluble in| sparingly soluble in ethanol; soluble in ‘ethanol; soluble in acetone in acetone in dimethyl sulfoxide, in dimethyl sulfoxide, in chloroform, in | chloroform, in methanol & in dioxane. | 7 methanol & in dioxane. [3 [entiication z= — ‘Test -A-by Infra Red Complies Tnffared spectrom oblained with sample is concordant with reference spectrum of : | a Clobetasol Propionate WS - 4 DFE 7 ‘About 196°C 7 3 100.08 +98" to +104 (on dried basis) - _ _| [Loss on drying on > ot more than 2.0% _ 7_| Residue on ignition | 0.05% ‘Not more than 0.1% Heavy metals ‘Complies ‘Not more than 20 ppm ‘Organi Impurities 7 | 9 | iy Any individual impurity [079% ‘Not more than 1.09% ii) Total impurities _ 0.85% ‘Not more than 2.5% \ 10 | Assay (on dried basis) 100.00% ‘Not less than 97.0% & not more than i 102.0% [Residual solvents 7 7 Methylene chloride IND eae ‘Not more than 600 ppm ‘Acetone 80.84 ppm "Not more than $000 ppm 11 [Ethyl Acetate 7 ND. — "Not more than $000 ppm Methanol 34.82 ppm ~ "Not more than 3000 ppm [Pyridine ND. Not more than 200 ppm. DMF 11694 ppm "Not more than 880 ppm ‘Aaditional Test 1 [Particle size a = | 1 [15 Microns | Complies ~ [300% — - Remarks The sample complies! doesnot complies as per Specification T-FP-O9 USP) For Anuh Pharma Ltd. Seco Authorized Signatory. Office: 3-A Shivsagar Estate, North Wing, Dr. Annie Besant Road, Wor, Mumbai 400 018. India. x Tel.: +91-22-6622 7575 Fax: +91-22-6622 7600 /7500 Email: ‘anun@sk1932.com CIN : L24230MH T960PLCO11586 WesServe Since 1932 Factory : Mis, Great Pacific Exports Pvt, Ltd, Plot No. D-5/8 & 5/9, TLC. Industrial Area, Turbhe Navi Mumbai- 400 703, IndiaANUH PHARMA LTD. ri | CERTIFICATE OF ANALYSIS Working Standard _| : | Clobetasol Propionate USP Sample Qty. 1x 500.0 mg Batch No APL/01289/K-18 AR. No. WS/003/2019 Mfg. Date | 11/2018 Exp. Date :| 10/2023 Sr. | Test Observation Limit No. 1 | Description white crystalline powder ~ "A white to cream, crystalline powder. 2 _| Solubility ‘Complies ‘As per USP 3 _ | Identification Complies ‘As por USP 4 | Melting range 196°C About 196°C 5 | Specific optical rotation 101.67" +98" to +104 (on dried basis) © | Loss on drying 0.24% Not more than 2.0% [7 [Residue on ignition 0.05% Not more than 0.1% 8 | Heavy metals ‘Complies | ‘Not more than 20 pg/gm 9 | Chromatographic purity 4) Any individual impurity 0.43% Not more than 1.0% if) Total impurities 0.43% Not more than 2.5% 10 | Assay (on dried basis) 99.35% ‘Not less than 97.0% & not more than 102.0% ‘Remarks: The sample complies as per USP Specification. Te 91-22-6622 7575 For Anuh Pharma Ltd. 6 jor? 7 Quality Control Dept. Office: 3-A Shivsagar Estate, North Wing, Dr. Annie Besant Road, Worli, Mumbai 400 018. india, Fax: +91-22-6622 7600 /7500 Email; anun@sk1932.com CIN : L24230MH1960PLC011586 Factory : Mis. Great Pacific Exports Pvt, Ltd, Plot No, D-6/8 & 6/9, T.7.C. Industral Area, Turbhe Navi Mumbai- 400 703, India,