Ceftiofur hydrochloride

Details:

ENTERPRISE STANDARD DESCRIPTIONOFF-WHITE OR YELLOW POWDER ASSAYCEFTIOFUR HCL 98% AREA NORMALIZATION METHOD PRODUCT NAME CEFTIOFUR HYDROCHLORIDEEXPIRY DATE 3 years ANALYSIS TESTSPECIFICATIONRESULTDESCRIPTIONOFF-WHITE OR YELLOW POWDEROFF-WHITE POWDERSOLUBILITYSOLUBLE IN DMF, SLIGHTLY SOLUBLE IN AQUEOUS SOLUTION OF SODIUM BICARBONATE 5% AND SLIGHTLY SOLUBLE IN METHANOLCONFORMSLOSS ON DRYING ≤5.0%4.5%PH2.0 ~ 3.02.5WATER ≤4.0%2.9%SULPHATED ASH≤0.5%0.3%BACTERIAL ENDOTOXINS≤0.2EU/mgCONFORMSSTERILECONFORMSCONFORMSRELATED SUBSTANCECEFOTAXIME≤1.0%0.3TOTAL RELATED SUBSTANCES≤2.0%1.0ASSAYCEFTIOFUR HCL≥98%(AREA NORMALIZATION METHOD)98.7%MICRONIZED90% LESS THAN 10 MICRONCONFORMSCONCLUSIONTHE RESULTS CONFORM WITH ENTERPRISE STANDARD ENTERPRISE STANDARDDESCRIPTIONOFF-WHITE OR YELLOW POWDERASSAYCEFTIOFUR HCL 98% AREA NORMALIZATION METHOD PRODUCT NAME CEFTIOFUR HYDROCHLORIDEEXPIRY DATE 3 years ANALYSIS TESTSPECIFICATIONRESULTDESCRIPTIONOFF-WHITE OR YELLOW POWDEROFF-WHITE POWDERSOLUBILITYSOLUBLE IN DMF, SLIGHTLY SOLUBLE IN AQUEOUS SOLUTION OF SODIUM BICARBONATE 5% AND SLIGHTLY SOLUBLE IN METHANOLCONFORMSLOSS ON DRYING ≤5.0%4.5%PH2.0 ~ 3.02.5WATER ≤4.0%2.9%SULPHATED ASH≤0.5%0.3%BACTERIAL ENDOTOXINS≤0.2EU/mgCONFORMSSTERILECONFORMSCONFORMSRELATED SUBSTANCECEFOTAXIME≤1.0%0.3TOTAL RELATED SUBSTANCES≤2.0%1.0ASSAYCEFTIOFUR HCL≥98%(AREA NORMALIZATION METHOD)98.7%MICRONIZED90% LESS THAN 10 MICRONCONFORMSCONCLUSIONTHE RESULTS CONFORM WITH ENTERPRISE STANDARD