Amlodipine Besylate USP Bisphenol A type Compounds Test Specification Min Max CLARITY

Test Specification Min Max CLARITY OF SOLUTION TO PASS TEST TO PASS TEST VISUAL TRANSITION INTERVALS pH 6

05% beta-LACTOSE 4% RETEST DATE

01 COLOR (APHA) 15 RESIDUE AFTER EVAPORATION 0

01% RESIDUE AFTER EVAPORATION 0

00% MELTING RANGE 143� - 148�C 143� - 148�C WATER DETERMINATION 0

Amlodipine Besylate USP Bisphenol A type Compounds Test Specification Min Max CLARITYTest 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