Amlodipine Besylate USP Bisphenol A type Compounds 01 COLOR (APHA) 15 RESIDUE

01 COLOR (APHA) 15 RESIDUE AFTER EVAPORATION 0

Test Specification Min Max APPEARANCE YELLOW TO BROWIN YELLOW TO BROWIN

3 ppm GOLD (Au) 0

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

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

Amlodipine Besylate USP Bisphenol A type Compounds 01 COLOR (APHA) 15 RESIDUETest 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