Clarithromycin
CAS No.: 81103-11-9
Product Name: Clarithromycin
CAS#81103-11-9
Package: 25kg/drum
Delivery time: in stock for prompt shipment.
Dangerous goods or not: Not
Country of origin: China
CAS#81103-11-9
Package: 25kg/drum
Delivery time: in stock for prompt shipment.
Dangerous goods or not: Not
Country of origin: China
Description
Spec of Clarithromycin :
| Items | Specification | Results |
| Appearance | White or almost while,cryslalline powder | White crystalline powder |
| Solubility | Soluble in acetone ,methylene chloride; slightly soluble in anhydrous ethanol, in methanol, and in acetonitrile, and in phosphate buffer at pH values of 2 to 5: practically insoluble in water. | Conforms |
| Identification | IR: Conforms to the spectrum of Clarithromycin RS. | Conforms |
| HPLC:The retention time of the major peak of the Sample solution corresponds to that of Standard solution , as obtained in the Assay | Conforms | |
| Appearance ef solution | Clear or not more opalescent than reference suspension Ⅱand not more intensely coloured than reference solution Y7. | Conforms |
| Specifc optical rotation | -94°~-102°(Anhydrous substance, 10mg/ml methylene chloride) | -98.2° |
| Water | ≤2.0% | 0.21% |
| Residue on lgnition | ≤0.2% | 0.03% |
| Crysallinity | Meets the requirements | Conforms |
| PH | 8.0- 10.0 | 9.2 |
| Impurity A | ≤1.0% | 0.26% |
| Impurity B | ≤1.0% | 0.1% |
| Impurity C | ≤1.0% | ＜1.0% |
| Impurity D | ≤1.0% | 0.2% |
| Impurity E | ≤1.0% | 0.37% |
| Impurity F | ≤1.0% | 0.2% |
| Impurity G | ≤1.0% | ＜1.0% |
| Impurity H | ≤1.0% | ＜1.0% |
| Impurity I | ≤1.0% | Not detected |
| Impurity J | ≤1.0% | Not detected |
| Impurity K | ≤1.0% | Not detected |
| Impurity L | ≤1.0% | ＜1.0% |
| Impurity M | ≤1.0% | Not detected |
| Impurity N | ≤1.0% | Not detected |
| Impurity O | ≤1.0% | Not detected |
| Impurity P | ≤1.0% | ＜1.0% |
| Any impurity greater than 0.4% | Not more than 4 | 0 |
| Any unspecified impurity | ≤1.0% | ＜1.0% |
| Total impurities | ≤3.5% | 1.1% |
| Assay(HPLC) | 96.0%-102.0%(Anhydrous substance) | 98.5% |
| Residual solvents(GC) | Ethanol≤5000ppm | Not detected |
