Item | Standard | Results | |
Appearance | A white or almost white crystalline powder; Odorless or has a faint odor | Conforms | |
Solubility | Freely soluble in water and in dimethyformamide; very slightly soluble in acetone | Conforms | |
Identification | IR spectrum of sample conforms to that of reference standard | Conforms | |
Specific optical rotation | +135~+150° | +142° | |
Water | 3.1%-6.0% | 3.8% | |
pH | 3.0-5.5 | 4.4 | |
Related Substances | Impurity A≤0.5% | 0.11% | |
Impurity B≤0.5% | 0.12% | ||
Impurity C≤0.20% | 0.10% | ||
Unidentified≤0.10% | 0.03% | ||
Total Impurities≤2.0% | 0.6% | ||
Heavy metals | ≤5ppm | <5ppm | |
Bacterial endotoxins | ≤0.50IU/mg | <0.5IU/mg | |
Total aerobic microbial count | ≤1000cfu/g | Meets the requirement | |
Total combined yeasts and molds count | ≤100cfu/g | Meets the requirement | |
N-Butanol | ≤0.5% | No detected | |
Acetone | ≤0.5% | No detected | |
Lincomycin B | ≤5.0% | 2.6% | |
Assay (anhydrous substance) | Sum of the contents of Lincomycin Hydrochloride and Lincomycin B Hydrochloride: 96.0-102.0% | 98.4% |