Procainamide Hydrochloride USP size:500 GM Test Specification Min Max APPEARANCE

Test Specification Min Max APPEARANCE PURE

20% LOSS ON DRYING 8% HEAVY METALS 40 ppm MICROBIAL LIMITS: ESCHERICHIA COLI NEGATIVE SALMONELLA NEGATIVE

01% TITRATABLE ACID 0

5 ppb GALLIUM (Ga) 1 ppb GERMANIUM 1 ppb HAFNIUM 0

Test Specification Min Max MELTING POINT 97

Procainamide Hydrochloride USP size:500 GM Test Specification Min Max APPEARANCETest Specification Min Max ASSAY (DRIED BASIS) 98 102. 00% MELTING RANGE 165 169C LOSS ON DRYING 0. 30% RESIDUE ON IGNITION 0. 10% FREE p AMINOBENZOIC ACID 0. 10% ORDINARY IMPURITIES 2. 00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION (A) SPECTRUM SPECTRUM IDENTIFICATION (B) Rf MATCHES Rf MATCHES EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS AS REPORTED AS REPORTED