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Test Specification Min Max APPEARANCE GOLDEN-BROWN TO GOLDEN-BROWN TO PARTICLE SIZE 40 - 80 MESH 40 - 80 MESH MOISTURE 10% MICROBIAL LIMITS: TOTAL PLATE COUNT 10000/g YEAST AND MOLD 500/g ESCHERICHIA COLI NEGATIVE SALMONELLA NEGATIVE
01% CHLORIDE (Cl) 1 ppm
50% HEAVY METALS 0
00% MELTING RANGE 153
) 250 C (dec
Enalapril Maleate USP size:5 GM Test Specification Min Max APPEARANCETest Specification Min Max ASSAY (DRIED BASIS) 98 102. 00% SPECIFIC ROTATION, [a][@D@]20 41. 0 to 43. 5 41. 0 to 43. 5 LOSS ON DRYING 1. 00% RESIDUE ON IGNITION 0. 20% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED ORGANIC IMPURITIES: RELATIVE RETETION TIME >1. 10 1. 00% ANY OTHER IMPURITY 0. 30% TOTAL IMPURITIES 2% IDENTIFICATION (A) SPECTRUM MATCH SPECTRUM MATCH IDENTIFICATION (B) RETENTION TIME RETENTION TIME EXPIRATION DATE DATE OF
