Doxylamine Succinate USP size:5 GM Test Specification Min Max PURITY

Test Specification Min Max PURITY (HPLC) 98% PURITY (Nonaqueous Titration) 98% SPECIFIC ROTATION

00% (n-HEXANE) 60% LIQUID CHROMATOGRAPHY SUITABILITY TO PASS TEST TO PASS TEST ULTRAVIOLET ABSORBANCE (1 cm cell vs

0 LEAD 2 mg/kg LOSS ON DRYING 0

4 ULTRAVIOLET ABSORBANCE TO PASS TEST TO PASS TEST AMMONIUM HYDROXIDE Ppt

00% MERCURY (Hg) 1

Doxylamine Succinate USP size:5 GM Test Specification Min Max PURITYTest Specification Min Max ASSAY (DRIED BASIS) 98 101. 00% MELTING RANGE WITHIN 3. 0 C WITHIN 3. 0 C LOSS ON DRYING 0. 50% RESIDUE ON IGNITION 0. 10% VOLATILE RELATED COMPOUNDS TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST