MASTER FORMULA RECORD FOR Pregabalin 75 mg Capsule
TABLE OF CONTENTS S. NO. TITLE Page No. 1.0 PRODUCT DETAILS 02 of 06 2.0 MANUFACTURING FORMULA 02 of 06 3.0 LIST OF EQUIPMENTS 02 of 06 4.0 GENERAL PRECAUTIONS 02-03…
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ANALYTICAL METHOD VERIFICATION PROTOCOL OF ASCORBIC ACID
Analytical Method Verification Protocol Cum Report ASCORBIC ACID TABLETS IP (500mg) (As per ICH guidelines) This document is an exercise on Analytical Method Validation of the various analytical Methods used in determination of active ingredients…
Process Validation of Terbutaline Sulphate, Ambroxol HCl, Guaiphenesin and Menthol Syrup
Product Name : Generic Name : Terbutaline Sulphate, Ambroxol HCl, Guaiphenesin and Menthol Syrup Type of Validation : Concurrent Validation Reason for Validation : Batch Size :…
ANALYTICAL METHOD VALIDATION/VERIFICATION PROTOCOL OF ESOMEPRAZOLE CAPSULES
Analytical Method Validation Protocol FOR ASSAY OF Esomeprazole Capsules (40mg) (As per ICH guidelines) (BY HPLC) Quality Control Department CONTENTS Sr. No Contents Page No. A Post-Approval 3 B Objective 3 C Method Summary 3…
ANALYSIS METHOD OF ESOMEPRAZOLE GASTRO-RESISTANT CAPSULES(40 mg)
GENERAL MATERIAL INFORMATION General Information Esomeprazole Gastro-resistant hard gelatin capsules contains Esomeprazole Magnesium Trihydrate pallets & dummy pallets. Categories Antiulcer Composition Each Hard gelatin capsule contains: Esomeprazole Magnesium Trihydrate IP……………………….40 mg Reference Indian Pharmacopoeia…
ANALYSIS METHOD OF DOMEPERIDONE TABLETS
GENERAL MATERIAL INFORMATION General Information Domperidone uncoated tablets is consisting of Domperidone and Excipients. Categories Antiemetic Composition Each film coated tablet contains: Domeperidone IP …………10 mg Reference Indian Pharmacopoeia 2022 Sample Quantity Chemical…
ANALYSIS METHOD FOR CINNARIZINE AND DIMENHYDRINATE TABLETS
GENERAL MATERIAL INFORMATION General Information Cinnarizine and Dimenhydrinate film coated tablets is consisting of Cinnarizine and Dimenhydrinate and Excipients. Categories Antihistamine Composition Each film coated tablet contains: Cinnarizine IP …………20 mg Dimenhydrinate……… 40…
ANALYSIS METHOD OF PROCYCLIDINE HYDROCHLORIDE TABLETS IP
GENERAL MATERIAL INFORMATION General Information Procyclidine Hydrochloride uncoated tablets is consisting of Procyclidine Hydrochloride and Excipients. Categories Composition Each film coated tablet contains: Procyclidine Hydrochloride IP …………2.5 mg & 5 mg Reference Indian…
SOP For Root Cause Analysis
1.0 OBJECTIVE: To lay down the procedure and guidance for conducting investigation of various non-conformities at manufacturing site to identified the root cause and recommend the correction and preventive action. 2.0 SCOPE: The…
Analysis method for VALSARTAN TABLET
GENERAL MATERIAL INFORMATION General Information Valsartan film coated tablets is consisting of Valsartan and Excipients. Categories Antihypertensive Composition Each film coated tablet contains: Valsartan IP………………80 mg &160 mg Reference Indian Pharmacopoeia 2022 Sample…