Item | Specification |
Appearance | Light cream-colored to light tan crystalline powder. |
Solubility (annual) | Freely soluble in benzene and in chloroform; soluble in ethyl acetate and in alcohol; slightly soluble in methanol and in fiexed oils; practically insoluble in water. |
Identification | Infrared Absorption: meets the requirement |
HPLC: meets the requirement | |
Limit of mercapto compounds | ≤0.10mL of 0.010N iodine is consumed |
Organic impurities | Related compound B ≤0.2% |
Related compound A ≤0.2% | |
Related compound C ≤0.2% | |
Related compound D ≤0.3% | |
Epimer ≤0.3% | |
Related compound I ≤0.1% | |
Any unspecified impurity ≤0.10% | |
Total impurities ≤1.0% | |
Optical rotation | -41°~ -45° |
Loss on drying | ≤0.5% |
Residual solvents (In-house) | Methanol ≤3000ppm |
Tetrahydrofuran ≤720ppm | |
DMF ≤880ppm | |
Particle size (In-house) | 95% not more than 20 microns |
Assay | 97.0% ~103.0% on the dried basis |