¥ WANBLIRY I Certificate of Analysis [Product : Metformin Hydrochloride USP. Batch No. = MTO7410821 Mig. Date = May, 2021 Exp. Date Apr, 2026 Dispatch Quantity = 1350 Kg No. of Containers : 27 Customer Name: AURACARE PHARMA PVT LTD, INDIA { Test Result ‘Specification | Description ‘White erystals White erystals Solubility Freely soluble in water, slightly] Freely soluble in water, slightly soluble in soluble in alcohol, practically | alcohol, practically insoluble in acetone insoluble in acetone and in| and in methylene chloride. methylene chloride, 3 | Tentification AIR | 7 Infrared spectrum of sample should be i Caxsoists concordant with that of working standard ‘B. Reaction of chlorides Positive ‘Should be positive The ees time of major peak of the 7 sample solution corresponds to that of the eee Soap standard solution, as obtained in the assay | by HPLC 4 | Coss on drying ain Not more than 0.5% (at 105°C for 5 hours ) “ 3__| Residue on ignition 0% Not more than 0.1% 6 Related substances (By HPLC) Iimpurity- A I (Cyanoguanidine| | 0.003 % Not more than 0.02% ‘Any other impurity 0.03 % ‘Not more than 0.1% | Total impurities 0.05 % ‘Not more than 0.5% 7 | Assay by HPLC ae (on dried basis) i 100.2% 98.0% to 102.0% Additional Tests 8 | Particle Size by Sieve On 20 mesh 99.8 % Not less than 90% passes through 20 mesh On 40 mesh 74.5% ‘Not less than 20% passes through 40 mesh { ‘On 60 mesh 473% ‘Not less than 30% passes through 60 mesh 9 Residual solvents by GCHS Methanol 127 ppm ‘Not more than 1000 ppm | Xylene Below Detectable Limit _ | Not more than 500 ppm Remarks: The product complies with USP-43 / In-house andCustomer specifications. Declaration: Product is free from animal derived materials and is manufactured from synthetic sources only. Prepared by Reviewed by Approved by ie a Sr, Executive-QC Manager-QC Sr, Matager- QA. Date: O8loshovt Date: exes Date ae o ‘Werks: Warbury Litited, Doctors Orgarse Choricals Division K:Windalaparr - 688 217, agavaram Mandal, West Godavari Dstiet. Andhra Pradesh, Inia. Tor-81-£818-284 240,284 34, ax. 81-8810-284 350 FRegd Office : 10h Flo, B-Wing, BSEL, Tech Park, Se:tor-20A, Ope. vash raiay stn, Vasry Navi Mumba-400703 (NDIA) Tol 91-20-6794 2202, Fax: 91-22-6794 2119/353& WANBURY Certificate of Analysis Product Metformin Hydrochloride USP Batch No. = MTO7420521 Mig. Date May, 2021 Exp. Date ‘Apr. 2026 Dispatch Quantity: 1330 Kg No. of Containers :27 Customer Name» AURACARE PHARMA PVT LTD, INDIA. S.No | Test Result Specification 1_| Description White crystals White erystals 2_| Solubility Freely soluble in water, slightly] Freely soluble in water, slightly soluble in soluble in alcohol, practically | alcohol, practically insoluble in acetone insoluble in acetone and in| and in methylene chloride. methylene chloride. [3 [Haentification AAR Inffared spectrum of sample should be concordant with that of working standard. B. Reaction of chlorides Positive ‘Should be positive The retention time of major peak of the | sample solution corresponds to thet of the Concordant ers ‘Complies: standard solution, as obtained in the assay by HPLC 7 | Lesson dying ee ‘Not more than 0.5% | (a 105°C for 5 hours ) ae $s Residue on ignition I 0.04 %. Not more than 0.1% 6 Related substances (By HPLC) Tmpurity- A | (Cyanoguanidine) 0,003 % | Not more than 0.02% Any other impurity 0.02 % Not more than 0.1% _ | Total impurities 0.04% ‘Not more than 0.5% [7 Assay by HPLC | (on dried basis) 99.7% 98.0 % to 102.0 % Additional Tests | 8 [Panicle Size by Sieve ‘On 20 mest WT% [ Not less than 90% passes through 20 mesh | (On 40 mesh 745% Not less than 20% passes through 40 mesh ‘On 60 mesh L_ 3.4% ‘Not less than 30% passes through 60 mesh [Residual solvents by GCH: Methanol T 14d ppm ‘Not more than 1000 ppm Xylene Below Detectable Limit _ | Not more than 500 ppm Remarks: The product complies with USP-43 / In-house andCustomer specifications. Declaration: Product is free from animal derived raaterials and is manufactured from synthetic sources only Prepared by Reviewed by Approved by a B Eescrtoe 0G Manager-QC aloe Sr. Maniiger— QA pate: O8los}rer] Date: Date: oe Works: Wanbury Limitad, Doctors Organic Chemicals Dvsion, K. Ilindalaparu ~ 536 217, kagavaram Mandal, West Godavari Dstt, Andhra Pradesh, ida, To: 81-8819-284 249, 284 348, ox 91-8810-284 350. Regd. fice: 10th Flor, B-Wing, BSEL, Tech Park, Seclor-298, Opp. ashy ralvay sn, Vash Navi Mumba-400709, (NOIA) Tel 91-22-6704 2202, Fax :91-20-6788 29111358_£ WANBLURY [ Certificate of Analysis Product Metformin Hydrochloride USP Batch No. 2 MT07430521 Mig. Date May, 2021 Exp. Date = Apr, 2026 Dispatch Quantity: 1350 Kg [ No. of Containers : 27 [Customer Name _: AURACARE PHARMA PVT.LTD, INDIA SNo [Tes Result ‘Specification Description White crystals White crystals 4 7] Say Freely soluble in water, slightly] Freely soluble in water, slightly soluble in soluble in alcohol, practicelly | alcohol, practically insoluble in acetone insoluble in acetone and and in methylene chloride. methylene chloride. 3 [Wentification AIR Tniared spectrum of sample should be Ceca sidan ft Seay anda, | 'B, Reaction of chlorides: Positive Should be positive “The retention time of major peak of the sample solution corresponds to that of the | rue Gone Stanerd slution as balned inthe asey | by HPLC . | Loss on drying nei. ‘Not more than 0.5% | I. (at 105°C for 5 hours ) 5 _| Residue 0.07 % Not more than 0.1% 6 Related substances (By HPLC) Impurity- A T | (Cyanoguanidine) 0.004 % | Not more than 0.02% Any other impurity 0.03 % | Not more than 0.1% Total impurities 0.03% ‘Not more than 0.5% 7 | Assay by HPLC I | (on dried basis) 8% 98.0 % to 102.0% Additional Tests. 8 Particle Size by Sieve On 20 mesh 99.7% ‘Not less than 90% passes through 20 mesh On 40 mesh TA% ‘Not less than 20% passes through 40 mesh ‘On 60 mesh 6.1% Not less than 30% passes through 60 mesh 9 Residual solvents by GCHS. [Methanol 173. ppm ‘Not more than 1000 ppm Xylene |___ Below Detectable Limit Not more than 500 ppm Remarks: The product complies with USP-43 / In-house andCustomer specifications, Declaration: Product is free from animal derived materials and is manufactured from synthetic sources only Prepared by Reviewed by Approved Kuh f eo Manager-QC odetheou Sr. Manager QA ate: Date: xo ‘Werks: Wanbury Limited, Doctors Organ Chemicals Division, K llindslaparu- £94 217, hagavaram Mandal, Vest Gedaver Disc Andtva Pradesh, led, Tol 81.8819-284 249, 284949, fx 91-8819-234 360 Regd. Office : roth Floor, Wing, BSEL, Tech Park, Sestor-30A, Opp. vashi ila st, Vashi Nav Mumbel-400703. (NDIA) ‘Tol 91-22-6794 2202, Fax: 91226794 21111993¥ WANBURY | Certificate of Anal | Product Metformin Hydrochloride USP Baich No. = MT07440521 | Mfg. Date = May, 2021 Exp. Date = Apr, 2026 | Dispatch Quantity : 1200 Kg No. of Containers : 24 | [Customer Name _; AURACARE PHARMA PVT LTD, INDIA (SIN | Test Result Specification 1_| Deseription White crystals ‘White crystals 2 | Solubility Freely soluble in water, slightly] Freely soluble in water, slighily soluble in | soluble in alcohol, practically | alcohol, practically insoluble in acetone insoluble in acetone and in| and in methylene chloride. | methylene chloride. 3 | Wentification a | ATR Infrared spectrum oF sample should be Roneoedert ponaaaintorttat sfowting standard. B, Reaction of chlorides Positive Should be positive ‘The retention time of major peak of the P sample solution corresponds to that of the GPUS Eomelics asard plulon a brane it tease by HPLC [4 [Toss on drying oF Not more than 0.5% atlO5°C for Shows) | i ‘S| Residue on ignition COS % ‘Not more than 0.1% 6 | Related substances (By HPLC) Impurity- A (Cysnoguaniine) 0.003 Not more than 0.02% [Any other impurity 002 % Not more than 0.1% Total impurities 0.04% Not more than 0.5% 7_| Assay by HPLC (on dried basis) 99.4% 98.0% to 102.0% | Additional Tests 8 | Panicle Size by Sieve ‘On 20 mesh 7% Not less than 90% passes through 20 mesh | ‘On 40 mesh 74.5% Not less than 20% passes through 40 mesh ‘On 60 mesh 16.6% Not less than 30% passes through 60 mesh | 9 | Residual sohvenis by GCHS | ‘Methanol im 154 ppm ‘Not more than 1000 ppm [Xylene Below Detectable Limit | Not more than $00 ppm Remarks: The product complies with USP-43 / In-house andCustomer specifications. Declaration: Product is free from animal derived materials and is manufactured from synthetic sources only. Prepared by Reviewed by, & Approved by Sr. Exeeutive-QC Manager-QC A Date: gglosiwor} Date: pelosbe ‘Werks: Wanbury Limited, Doctors Organie Chemicals Division, K, lindlapart 534 217, ragavaram Mandal, West Gedavari Distt, Anda Pradesh, ind “Tel-91-8810-288 249, 284 349, ox: 91-8819-284 360 Regd. Offa 10th Flor, B-Wing, BSEL, Tech Park, Secor-30A; Opp. vashiraiway sin; Vashi Navi Mumba 400708. (INDIA) ‘Ta, ‘ergn-mrse seep: Fau-S0-n87es SvT4Ean: