Clindamycin HCL, CAS 21462-39-5
Test items |
Specification |
Results |
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Appearance |
White or almost white crystalline powder |
White crystalline powder |
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Identification IR HPLC |
IR spectrum should correspond to that of the reference standard Retention time of the sample should be consistent with the reference |
Conform Conform |
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Crystallinity |
Should meet the requirement |
Conform |
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pH |
3.0~5.5 |
4.2 |
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Water |
3.0~6.0% |
3.9% |
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Related substances Clindamycin B(RRT at 0.65) 7-Epi Clindamycin(RRT at 0.8) Individual unknown impurity Total impurities |
NMT 2.0% NMT 4.0% NMT 1.0% NMT 6.0% |
0.2% 0.1% 0.2% 0.7% |
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Residual Solvents Acetone Ethanol N,N-dimethyformamide Chloroform |
NMT 3000ppm NMT 3000ppm NMT 500ppm NMT 30ppm |
118ppm ND ND ND |
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Tapped Density(in-house) |
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894.3mg/ml |
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Loose Density(in-house) |
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545.3mg/ml |
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Assay (On anhydrous basis) |
NLT 800μg/mg |
904μg/mg |
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Conclusion |
The product conforms with USP41. |