发布日期：2020-09-04 09:58 浏览次数：
White or almost white crystalline powder, No odor and bitter.Insoluble in water, freely soluble in chloroform, soluble in acetone or ethyl acetate, sparingly soluble in methanol of alcohol.
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TESTS |
USP Specifications |
Results |
|
Identification Tests (IR) |
Conforms to the reference spectrum |
Conforms |
|
Specific optical rotation |
-89°-95° |
-92° |
|
Crystallinity |
Should conform to requirements |
Conforms |
|
PH |
Between 7.5 and 10.0 |
8.7 |
|
Water |
≤2.0% |
0.92% |
|
Residue on ignition |
≤0.3% |
0.04% |
|
Residual Solvents |
Ethanol≤0.5% |
Not detected |
|
Heavy metals |
≤20ppm |
<20ppm |
|
Assay (HPLC, dried substance) |
9601040ug/mg |
981ug/mg |
|
Conclusion: Conforms to USP 28 specification for Clarithromycin |
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