Clarithromycin 6-O-Methylerythromycin klaricid
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Index |
Standard |
Test Result |
Appearance |
White to off-white,crystalline powder |
White crystalline powder |
Solubility |
Solution in acetone;slightly soluble in dehydrated alcohol,in mrthanol,and in acetonitrile;parctically insoluble in water;slightly soluble in phosphate buffer at PH value of 2 to 5. |
Complies |
Identification (By IR) |
Corresponding to RS |
Complies |
Appearance of solution |
Not more opalescent than reference solution Ⅱ |
Clear |
Specific optical rotation |
-89°~-95° |
-92° |
Crystallinity |
The particles show birefringence (interference colors) and extinction position |
Complies |
PH |
7.5~10.0 |
8.8 |
Moisture |
≤2.0% |
0.3% |
Residue on ignition |
≤0.3% |
0.06% |
Heavy metals |
≤0.002% |
Complies |
Assay (By HPLC) |
Clarithromycin contains not less than 960ug and not more than 1040ug of C38H69NO13 per mg,calculated on the anhydrous basis. |
979ug/mg |
Additionalin-house tests: |
||
Bulk density |
≥0.45g/ml |
0.52g/ml |
Tapped density |
≥0.54g/ml |
0.60g/ml |
Particle size |
≥90% passes trough 40 B.S.Sieve |
Complies |
Conclusion |
Conform to USP28. |
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
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