Amlodipine Besylate USP Bisphenol A type Compounds 01% RESIDUE AFTER EVAPORATION 0

01% RESIDUE AFTER EVAPORATION 0

Test Specification Min Max PURITY (Neutralization titration) 95

5 % INSOLUBLE SUBSTANCES TO PASS TEST LEAD (Pb) 2 mg/kg LOSS ON DRYING 1% IDENTIFICATION TO PASS TEST RETEST DATE

0% ACIDITY (as CH[@3@]COOH) 0

05% beta-LACTOSE 4% RETEST DATE

Amlodipine Besylate USP Bisphenol A type Compounds 01% RESIDUE AFTER EVAPORATION 0Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102. 00% OPTICAL ROTATION, [a] 20D 0. 10 to +0. 10 0. 10 to +0. 10 WATER DETERMINATION 0. 50% RESIDUE ON IGNITION 0. 20% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST