€& NAKODA CHEMICALS LTD. (AN ISO 9001 ; 2008 and WHO-GMP APPROVED COMPANY) CERTIFICATE OF ANALYSIS Product : FAMOTIDINE-EP QC Ref. No. : FM'C/1412004 Batch No. ; FM-14120040 Date of analysis 2 02/01/2015 Mfg. Date: DEC-2014 Batch Qty. Retest Date: NOV-2018 Dispatch Qty. ‘Customer Name: ---NA--- Dispatch Cont. No. S.No. TEST SPECIFICATION RESULT « apm White or yellowish - white erystalline Yellowish white Pe L powder or erystals. ___| crystalline powder _ Very slightly ooluble in water, frocly soluble in glacial acetic acid, very slightly soluble in 2 | Solubility anhydrous ethanol, practically insoluble in | Complies ethyl acetate. It dissolves in dilute mineral acids. TR spectra of test sample exhibit similar 3 | Identification ty 12 | intensities of absorption at the same wave | Complies number as of reference standard 4 | Appearance of ‘The solution is clear and not more intensely | (io solution coloured than reference solution BY a Related substances by HPLC i) Impurity A Not more than 0.15 % 0.05 %. ii) Impurity B Not more than 0,15 % Not detected 5 | +H) Impurity C Not more than 0.3 % 0.1% iv) Impurity D Not more than 0.3 % 0.1% y) Impurity F Not more than 0.15 % 0.03% vi) Impurity G Not more than 0.15 % 0.02.% PREPARED BY: K.S.Sandeep | CHECKED BY : P.D.Prakash APPROVED BY : M.G:Madhu Babu DESIGNATION: Chemist@QA | DESIGNATION: SrManager - QO | DESIGNATION: Sr. Manager -QA SIGNATURE sianatune (Cytul— signature el DATE etiletlang [DATE z oploe hi DATE Bite Note: COA for Reference (Typical GOA) Page 1 of2 CIN No. U241 $PL.C009703 Plot No, 64/A, Phase - I, IDA., Jeedimetla, Hyderabad - 500 055, Telangana, INDIA. Ph. 040-23447755/S6/57. Fax. 040-23447754€& NAKODA CHEMICALS LTD. (AN ISO 9001 : 2008 and WHO-GMP APPROVED COMPANY) Product FAMOTIDINE-EP QC Ref. No. : FM'C/1412004 Batch No. : FM-1412004¢ Date of analysis =: 02/01/2015 Mfg. Date : DEC-2014 Batch Qty. to NA- Retest Date: NOV-2018 Dispatch Qty, NA Customer Name: ---NA--- Dispatch Cont. No. ‘NA~- S.No. TEST SPECIFICATION RESULT vil) Any unknown | Not more than 0.10 % 0.03 % Z impurity vil) Total impurities | Not more than 0.8 % 05% 6 | Heavy metals Not more than 10 ppm Less than 10 ppm 9 | Assay basis 7 | Loss on drying Not more than 0.5% 02% 8 | Sulphated ach Not more than 0.1% 0.04% Not less than 98.5% and Not more than 101.5% as CablisN7O2Ss calculated in dried | 100.1% Residual solvents a) Acetone b) Isopropyl alcobol 10 “| ©) Methanol Not more than 1000 ppm Not more than 1000 ppm Not more than 1000 ppm Below detectable limit, Below detectable limit 498 ppm. Remarks: The product Co: mplies / does-net-eemply with the EP Specifications. PREPARED BY: K.S.Sandeep CHECKED BY : P.D.Prakash APPROVED BY : M.G.Madhu Babu DESIGNATION: Chemist QA DESIGNATION: Sr. Manager - QC DESIGNATION: St. Manager - QA STGRATORE “SO, | ONATURE SIGNATURE: —— y 5 AT AE 7 pate © lose | PM = “Asli Note: COA for Reference (Typical COA) Page 2 of 2 CINNo. U24 11418 1009703