Clindamycin Phosphate is used primarily to treat infections caused by susceptible anaerobic bacteria, including infections of the respiratory tract,skin and soft tissue infections, and peritonitis.In patients with hypersensitivity to penicillins,Clindamycin Phosphate may be used to treat infections caused by susceptible aerobic bacteria as well.
Clindamycin Phosphate is a semi synthetic derivatives of clindamycin,has no antibacterial activity in vitro enter the body quickly hydrolyzed to clindamycin and to show its pharmacological activity,the antibacterial spectrum of antibacterial activity,and the therapeutic effect of clindamycin and the same,but its lipid solubility and permeability of Pickering mycin,oral or intramuscular injection and intravenous drip.
Clindamycin is used primarily to treat infections caused by susceptible anaerobic bacteria, including infections of the respiratory tract, skin and soft tissue infections, and peritonitis.In patients with hypersensitivity to penicillins, clindamycin may be used to treat infections caused by susceptible aerobic bacteria as well. It is also used to treat bone and joint infections, particularly those caused by Staphylococcus aureus. Topical application of clindamycin phosphate can be used to treat mild to moderate acne.
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Items |
Standard |
Result |
Characteristics | A white or almost white ,slightly hygroscopic powder | A white ,slightly hygroscopic powder |
Solubility | This product is easily soluble in water, slightly soluble in methanol, almost insoluble in ethanol, acetone | conform |
Identification | A:the infrared light absorption spectrum of this product should be consistent with that of the reference product B:the retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay |
Conform conform |
Crystallinity | Meets the requirements | conform |
PH | PH 3.5-4.5 | 3.8 |
Water by KF | ≤6.0% | 0.62% |
Organic impurities | ||
Lincomycin phosphate | ≤1.0% | 0.26% |
Lincomycin | ≤0.5% | None detected |
Clindamycin B phosphate | ≤1.5% | 0.21% |
7-epiclindamycin phosphate | ≤0.8% | 0.11% |
Clindamycin 3-phosphate | ≤0.3% | 0.064% |
Clindamycin | ≤0.5% | 0.16% |
Any individuai unspecified impurity: | ≤1.0% | 0.33% |
Total impurities | ≤4.0% | 1.2% |
Bacterial endotoxins test | <0.58EU/mg | <0.1EU/mg |
Residual solvents | Acetone≤0.5% ethanol≤0.5% methanol≤0.3% pyridine≤0.02% chlorofor≤0.006% |
None detected 0.002% None detected None detected None detected |
Assay | Not less than 758ug/mg on the anhydrous basis | 838ug/mg |
CONCLUSION | This product conforms with usp43 |
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