CAS number： 859-18-7
Molecular formula： C18H35ClN2O6S
molecular weight： 442.9983
Chemical structure：
| Name of Product: | Lincomycin hcl | |
| Shelf Life: | 3 years | |
| Specification: | EP8.0 | |
| Test Items | Specification | Results of Analysis |
| Characters | A white or almost white crystalline poweder; solubility conformed | Almost white crystalline powder; Solubility Conformed |
| Identification | A. The IR spectrum conforms to that obtained with the reference substance | A.The IR spectrum conforms to that obtained with the reference substance |
| B. Its solution gives reaction (a) of chlorides | B.Its solution gives reaction (a) of chlorides | |
| Appearance of solution | Clear and not more intensely coloured than reference solution Y6 | Clear and not more intensely coloured than reference solution Y6 |
| PH | 3.5-5.5 | 4.3 |
| Specific optical rotation | 135.0°-150.0° | 143° |
| Related substances | Impurity A≤0.5% | 0.3% |
| Impurity B≤0.5% | 0.2% | |
| Impurity C≤0.2% | 0.1% | |
| Any unspecified impurity≤0.10% | 0.08 | |
| Total impurities≤0.2% | 0.7 | |
| Heavy metals | Not more than 5ppm | Not more than 5ppm |
| Water | 3.1%-4.6% | 4% |
| Suphated ash | ≤0.5% | 0.1% |
| Particle size | 100% pass through 30mesh or 60mesh or 80mesh | 100% pass through 30mesh |
| Bacterial endotoxins | Less than 0.50IU/mg | Less than 0.50IU/mg |
| Residual solvents | n-Butanol:Not more than 5000ppm | 139ppm |
| Octanol:Not more than 2ppm | undetected | |
| Assay (anhydrous basis) | Sum of the contents of lincomycin hydrochloride and lincomycin B hydrochloride: 96.0%-102.0% | 100.7% |
| Lincomycin B hydrochloride: Not more than 5.0% | 3.2% |
