Items | Criteria |
Characteristics | A white or almost white,crystalline powder |
Identification | Infrared Absorption |
Crystallinity | Meets the requirements |
PH | Dissolve 0.2g in water and dilute to 20ml PH3.5-4.5 |
Residual Solvents |
|
Acetone | Not more than 0.5% |
Methanol | Not more than 0.3% |
Ethanol | Not more than 0.5% |
Pyriodine | Not more than 0.02% |
Water | Not more than 6.0% |
Bacterial endotoxins | Less than 0.58USP EU per mg/bf clindamycin |
Assay | Anhydrous substance less than 758ug of clindamycin per mg |