Amitriptyline Hydrochloride US- (DGF) UN2811, 6.1, PG III Tryptamines 50% LOSS ON DRYING 8

50% LOSS ON DRYING 8

442 EXPIRATION DATE MANUFACTURE DATE

Test Specification Min Max BARIUM 9950 - 10050 ppm 9950 - 10050 ppm EXPIRATION DATE

0 % SPECIFIC ROTATION +324 to +338 +324 to +338 LOSS ON DRYING 0

Amitriptyline Hydrochloride US- (DGF) UN2811, 6.1, PG III Tryptamines 50% LOSS ON DRYING 8Test Specification Min Max ASSAY (DRIED BASIS) 98 102. 00% pH OF A 1 IN 100 SOLUTION 5 6 LOSS ON DRYING 0. 50% RESIDUE ON IGNITION 0. 10% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES ACCEPTANCE CRI AMITRIPTYLINE RELATED COMPOUND A 0. 05% AMITRIPTYLINE RELATED COMPOUND B 0. 15% NORTRIPTYLINE 0. 15% CYCLOBENZAPRINE 0. 15% ANY INDIVIDUAL, UNSPECIFIED IMPURITY 0. 10% TOTAL IMPURITIES 1. 00% IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF