METROCHEM API PRIVATE LIMITED Unit: Plot No.: D-69/A(Part)&D-69, Phase-|,|.D.A., Jeedimetla, Quthoullapur Mandal, Medchal-Malkajgir District-500055, Telangana State, India. CIN: U24239TG2002PTC039223 contact@metroapi.com | www.metroapi.com CERTIFICATE OF ANALYSIS _ Storage Conon fice | [Ue ee Batch No TSMrarBODaOROND Das of Maui [7 [etry 2022 Preserve in ht iht-resistnt contain Stored at 25°C fesewsions allossed between 13°cand 10° ‘so. | Vest Speci 1. | Description An ol-white spherical pellets Te rio of the retenion times of the Esineprarale Result Offi spherical pellets (Content of Esomeprazole Magne 8. | Onanieimpurtes @4) 2. | heaton by HPLC peakinth sandal and the simple solaion shouldbe | 1.00 Ug. 3 Mas Coma Ee a a 4 Pat dens 0.709050 a0 ss hosp NUT 750%AO) of label amount of Esomeprazole 7 a. | Destin atpiecaae Baer Magne shoul be doled a Porpate Baer | 94S (1168) hn ieee ee | see NUT 904 else sil paseo . Pollet Stzm (ASTM) (%) LNMT 10.0% Pellets should pass through 161 Sno 7 | Rear PLC ia NLT 90.0% and NMT 110.0% of label ein ® 13) Omeprazole sulfone NMT05% os b) Any other lnividual Impurity NMTO2% ot ©) ‘Total Impurities NMT2.0% o7s 9. | Gastric Resistance (%) NET 850% of Esomeprazole should semain un ios - in QIN HCL aller hours 2 io, Merobiad Limits '2) Toil Microbial count NMI 100 efi 2% 1) Toval Fungal count Less than 10 ©) Escherichia col Should be Absent ‘Absent 4) Salmonella spp Should be Absent ‘sent ©) Staphylococcus aureus ‘Should be Abst Absent )_Psexdomona aeruginosa —_ Remar? The material conforms to above specifications ~T Checked by: IN Reckly ‘Approved by Designation : Sr. Manager-OC Designation Si a. Signature Date Tul waa Corporate Office: The Watermark, 3rd & 4th Floor, Plot No 11, Survey No 8, Whitefields, Kondapur, Hitech City, Hyderabad 600084, Telangana State, India. Tel: +91-40-69069999 asheMETROCHEM API PRIVATE LIMITED Unit-t: Plot No.: D-89/A(Part)&D-69, Phase-|,|.0.A., Jeedimetia, Quthbullapur Mandal, ‘Medchal-Malkajgiri District-500055, Telangana State, India. CIN: U24239TG2002PTCO39223 contact@metroapi.com | www.metroapi.com CERTIFICATE OF ANALYSIS Prot Name Esomeprazole Magnesium Falls 85% whe Reference J Ustrin house [rae ene Ne 1wiKR/AP ONO Batch No. | esisea/on2070029 | Date of Manufacturing | February 2022 Batch OW, [500.30 ke [Ba of Eni fe [Pawary 2005 Disp Quy. 500.00 ke ron.200 Custer Name |: | Mls. Cpis Mesical SR Maket mode [expt [some conttion | sensing hin conn. tr 25° xeon ld es 1nd IE Result ‘Specification 1. | Deserpt ‘An oft-white spherical pellets 0.70 100.90 ‘mount oF Esomeprazole ‘hos be dissolve in Phosphate Bur 937 {pH 68) within 30 minutes, NLT 90.0% Pellets should. passthrough 12 mesh and NMIT 10.0% Pellets should pass throug 16 mesh, il NM 110,0% of label clan 122 Dissolation in Phosphate Bulfer (pH 68) C% wi) 6. | Pellets Size (ASTM) (%) Conforms “ny by FPLC (Wa) [Esomeprazole Magnesium) 8 | Orpanic impurities (%) NLT 0. pelles The ral of the retention Tnes oF the Esomeprarare 2 | ldentieaion by HPLC pak in the stand’ andthe sample solution should be 1.00 : | 0.98-1.02_ iaseseeceecee se ets |e ces NMIS0 aie 030) Oft-white- spherical} 2) Omer sline NM 05% aus ®)Anyator nividalnpaity | NMI ds 3) oat npurtis Nir 20% on 9. Gastric Resistance (%) NLT 85.0% of Esomeprazole should remain un | 1014 Gisolvednd.N LCL ar hous Ta ea is 3) Tol Miri oue ‘NM oon ign | 3) Toa Fungal cot NK 00 eu Les than 1 | 3 excheracol Should be Abn ‘Abe 3) Salmon spy Should be Absent tee ) Baplylocoses ens Should be Absent sant | _ Tetsdomone sengison _| shouldbe ne ‘Abt owas The ell conforms to above specislons.Spccion No: FPESKTSPTTE RE a ‘Compiled by: V.S.L. Bhavani ‘Checked by: J.N- Reddy ‘Approved by: 1L-S.V. Prasda Ro Designation St Exeeutive-Qc Designation : Sr. Mangr-QC Siotire cf Signature = ira Vv; vn fin [oes ATOR) Dave ® Corporate Office: The Watermark, 3rd & 4th Floor, Plot No 11, Survey No 9, Whitefields, Kondapur, Hitech City, Hyderabad 500084, Telangana State, India. Tel: +91-40-69069990 fat arpean glen tzea = ]METROCHEM API PRIVATE LIMITED Unit: Pot No.: D-69/A(Part}&D-69, Phase-|. L.A, ‘Medchal-MalkajgitiDistrict-500055, Telangana State, ccontact@metroapi.com | www.metroapi.com Praduet Name Esomeprazole Magnesia CERTIFICATE OF ANALYSIS Jeedimetia, Quthbullapur Mandal, India, CIN: U24239TG2002PTC039223 m Piles 8.5% whe - T 0.00 ke Reference ‘USPrin house Drug License No. HURRIAPDOOGR Deh No, TES/n/2/2022020023 Date of Manufacturing Febroary 2022 Batch Qy 500.30 ke Dae of Expiry Jamary 2025 Remarks” The material conforms to above specifications, Specification Ni 4 Revision No-00 Dispatch Quy Date of Release Customer Name Mis. Caps Medical SRL Market mode Storage Condition Posere in tight light resistant condcners. Stared at.25 , 7 No, Vest Speitieation Result elliot OfRhite_ spherical 1 An off-white spherical pellets oe The ratio of the retention times of the Esomepeazae 2. | tdentificaton by HPLC ‘peak inthe standard and the sample solution should be 1.00 [3._| Moistwe Content by KEW) pars. Sooner ie 4 | Bulk density (wim!) 0.70 00.90 0.80 ee ‘i NLT 75.0%) oF label amount oF Esomeprazole Dissolution in Phosphate Buffer 5 Magnesiam should be dissolved in Phosphate Buller ous. | * | ores cow) yt eee i 7 = ‘NLT 90.0% Pellets should pass tough 12 mesh and canton Ki _| Beneeiee (aT [MY 10.0% Pellets should pass throug 16 mesh Sonttems ‘Assay by HPLC OH) : rade al mene NUT90OR&and NM HHNO%oflae hin | 1019 8 | Organic impurities (%) 2) Omeprazole sulfone NOT 0.5% ous bo) Any other Individual Impurity NMT 02% 06 ©) Total Impurities NM 2.0% 0.76, 9, | Gastric Resistance (%) NET 850% of Esomeprazole should remain un Ca dissolved in O.1N NCL aller 2 hours 4 To. | Mievabia iis '2) Total Microbial count NM 100 erg 0 1) Total Fungal cout NM 100 efu/gm | tess than 10 ©) Escherichia col Should be Absent ‘Absent 6) Salona spp Should be Absent “Absent ©) Staphylococets aureus Should be Absent Absent 1) Pseudomona aeruginosa Soul be Absent ‘Absent Canpiled by: WS... Bhavani Checked b Designation :St Execuive-QC Sipnature Signature [Das Daie Designation» Sr. Manager-QC ‘Approved by Designation by: LN Rely Corporate Office: The Watermark, 3rd & th Floor, Plot No 11, Survey No 9, Whitefields, Kondapur, Hitech City, Hyderabad 600084, Telangana State, India. Tel: +01-40-89060909 TSWV. Prasda Rao