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Product name |
Clobetasol propionate |
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Batch No. |
200302 |
Quantity |
100.0kg |
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Mfg. Date |
Mar.,21, 2020 |
Expiry date |
Mar.,20, 2023 |
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Specification |
USP38 |
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Items |
Standard |
Results |
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Description |
White or almost white crystalline powder |
almost white crystalline powder |
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Solubility |
Practically insoluble in water,slightly soluble in benzene and diethyl ether ,sparingly soluble ethanol, soluble in acetone and in dimethyl sulfoxide, in chloroform, in methanol and in dioxane |
Complies |
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Identification (IR) |
Complies with the Standard |
Complies |
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Specific Rotation |
+98°～+104° |
+101.9° |
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Melting point |
about 196℃ |
193.5～194.5℃ |
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Loss on drying |
Max.2.0% |
0.07% |
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Residue on ignition |
max. 0.1% |
0.04% |
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Heavy Metals |
max.20ppm |
Complies |
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Related Substances (HPLC) |
-Single impurity |
N.m.t 1.0% |
0.12% |
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-Sum impurity |
N.m.t 2.5% |
0.18% |
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Organic volatile impurities |
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THF |
Not more than 720ppm |
Complies |
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Methanol |
Not more than 3000ppm |
Complies |
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DMF |
Not more than 880ppm |
Complies |
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Pyridine |
Not more than 200ppm |
Complies |
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Dichloromethane |
Not more than 600ppm |
Complies |
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Ethanol |
Not more than 5000ppm |
Complies |
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Acetone |
Not more than 5000ppm |
Complies |
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Assay(HPLC,basis on drying) |
97.0%～102.0% |
99.4% |
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Packaging and storage: Preserve in tight, light-resistant containers. |
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Conclusion: The test product complies with the requirements of USP38. |
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