
Item | Specification |
Appearance | White to off-white, hygroscopic, crystalline powder. Is odorless or practically odorless, and has a bitter taste. |
Solubility | Freely soluble in water, practically insoluble in ethanol, in acetone, in chloroform, in benzene, and inether |
Identification | A.IR |
B:The retention time of the major peak of the sample solution corresponds to that of the standard solution as obtained in the assay. | |
Crystallinity | Meets the requirements |
PH | 3.5~4.5 |
Water | ≤6.0% |
Bacterial endotoxin | <0.581U/mg |
Related substances | Lincomycin phosphate ≤1.0% |
Lincomycin ≤0.5% | |
Clindamycin B phosphate ≤1.5% | |
7-epiclindamycin phosphate ≤0.8% | |
Clindamycin 3-phosphate ≤0.3% | |
Clindamycin ≤0.5% | |
Any individual un-specified impurity ≤1.0% | |
Total impurities ≤4.0% | |
Residual solvents | Ethanol ≤5000ppm Acetone ≤5000ppm Chloroform ≤60ppm Pyridine ≤200ppm Methanol ≤1000ppm |
Assay | ≥780μg/mg |
Clindamycin phosphate is a chemical semi-synthetic derivative of clindamycin, white or off-white crystalline powder at room temperature, odorless, bitter in taste, and hygroscopic. It has no antibacterial activity in vitro, and can be rapidly hydrolyzed into clindamycin after entering the body to exert pharmacological effects. Its mechanism of action, antibacterial spectrum, indications, and therapeutic effects are the same as those of clindamycin.