

| Model: | MOS81103-11-9 |
| CAS: | 81103-11-9 |
| Molecular formula: | C38H69NO13 |
| Molecular weight: | 747.9534 |
| Refractive index: | 1.526 |
| Density: | 1.18g/cm3 |
| Melting point: | 217-220℃ |
| Flash point: | 440.9°C |
| Vapour Pressur: | 5.06E-30mmHg at 25°C |
| Boiling point: | 805.5°C at 760 mmHg |
Clarithromycin (CAS 81103-11-9)
| ITEM | STANDARD | RESULT |
| Appearance | White or almost white crystalline powder | White crystalline powder |
| Soluble | Soluble in acetone; slightly soluble in dehydrated alcohol, in
methanol, and in acctonitrile, and in phosphate butter at PH values of 2 to 5; practically insoluble in water. |
Conforms |
| Indentification | IR: Conforms to the spectrum of Clarithromycin RS | Conforms |
| Appearance of solution | Clear or not more opalescent than refence suspension 2
and not more intensely coloured than reference solution 7. |
Conforms |
| Specific optical rotation | -94° ~ -102° (Anhydrous substance, 10mg/ml methylene chloride) | -99° |
| Crystallinity | Meets the requirements | Conforms |
| PH | 8.0 ~ 10.0 | 8.7 |
| Water | ≤ 2.0% | 0.21% |
| Sulphated ash | ≤ 0.2% | 0.03% |
| Heavy metals | ≤ 0.002% | < 0.002% |
| Related substances | Any single impurity ≤ 1.0% | 0.65% |
| Any impurityes greater than 0.4% ≤ 4 | 1 | |
| Total impurities ≤ 3.5% | 1.7% | |
| Assay (HPLC) | 96.0% ~ 102.0%(Anhydrous substance) | 97.4% |
| Residual solvents | Ethanol ≤ 5000 ppm | Not detected |
| Pyridine ≤ 200 ppm |
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