RIBS LIS EDS MANUFACTURERS OF QUALITY BULK PELLETS CERTIFICATE OF ANALYSIS ~~ Produet: Pantoprazale (Enteric Coated) 40mg and Domperidone (Sustained release) 30mg pellets Blend Batch No; PDVSH/030418 Mig Dae: Apr208 Exp Date: Mar2021 IMIG No- SHFD 26003721 Date sapling: 2008.21 uaa of sping S0gm Date af Amafsis 2004-21 Dat of port 26.0421 S.No TesT SPECIFICATION RESULT hansen ue aly range an Bh cofored 1 Description Oring and Blue colored Sphere Plas an Be 2 Pamoprozole Acid Nar 10% aaste Not ess thin 700% (0) of be elim shuld remain : a eee issolved in phosphite butler (pH 68) within 45 minutes, coer 1 Hour 15-400 Yew 2859 Yowiw 1 Dissolution 4° Rou 30-60% wry 4878 sa (Domperidone) 8* Hour 50 - 80.0 % wiw 74.32 Yowlw 12 How NLEM00% wie $981 Seu ee Each 270) f pellets blend ) | ea 1/0 mg Geng 0m) pot mg eee 2) 30 mg (27.0mg to 3.0m ees 2) Domperidone : : * o Related Substance by ; - HPLC for Pamtoprazoe ae nm 1. Related Compound-a AMT 03% Nb 6 2. Related Compound-B NMT 0.75% ND. 3. Related Compound-D&F NMT 0.2% 1.09% 4. Any other single impurity NMT 1.5%. an ___| 5: Potat impurities~ _ 5 Related Substance by 7 | HPLC for Domperione: Nar 0.5% uae 1. Single Max. Impurity NMT 2.0% OAM% 2. Total impurity par The sample angie WW Teapot o ave speSTCon a Analyst: Lokesh Reviewed by: N. Naresh Released by: J. shambhavi Disg: QC-Expeutive Disg: QC-Manager iss; QA-Manager ry ae ip Oy KO [Stabs Date: 2.6\o"\>1 Date: cor} : ate: Pe