Vancomycin Hydrochloride USP Chloroanthraquinone Test Specification Min Max APPEARANCE

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

00% SUBSTANCES DARKENED BY (H[@2@]SO[@4@]) TO PASS TEST TO PASS TEST RESIDUE AFTER IGNITION 0

Test Specification Min Max ASSAY (FeSO[@4@]) 86

Test Specification Min Max FDA LOT NUMBER DYE CONTENT IDENTIFICATION HEAVY METAL: ARSENIC (As) LEAD (Pb) MERCURY (Hg) EXPIRATION DATE

Test Specification Min Max SPECIFIC EXTINCTION E @ 600 nm

Vancomycin Hydrochloride USP Chloroanthraquinone Test Specification Min Max APPEARANCETest Specification Min Max POTENCY (AS VANCOMYCIN) 900 g mg pH OF A 50 mg ml SOLUTION @ 25[dC 2. 5 4. 5 COMPOSTION OF VANCOMYCIN TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED WATER DETERMINATION 5. 00% LIMIT OF MONODECHLOROVANCOMYCIN 4. 70% IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST