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Product Details
Clarithromycin
| Model NO.: | USP, EP |
|---|---|
| Standard: | USP31, EP6.0 |
Product Description
White or almost white crystalline powder;
Practically insoluble in water, soluble in acetone and in methylene chloride, slightly soluble in methanol;
IR conforms to the CRS spectrum.
Specific optical rotation: -94---102
Appearance of solution: Clear or not more than reference suspension II and not more intensely coloured that reference solution Y7.
Related substance:
Any impurity not more than 1.0%
Any impurity more than 0.4% not more than 4peaks
Total impurities not more than 3.5%
Water: Not more than 2.0%
Residual solvents: Ethanol not more than 0.5%
Rsidue on ignition not more than 0.2%
Heavy metals not more than 20PPM
Assay 96.0-102.0%
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