Item | Specification |
Appearance | White or yellowish powder |
Solubility | Practically insoluble in water, freely soluble in DMSO, practically insoluble in anhydrous ethanol and in heptanes. |
Identification | IR: Spectrum should comply with the WS |
HPLC-RT of sample under enantiometric purity test should comply with that of WS. | |
Water | ≤0.5% |
Sulphate ash | ≤0.1% |
Loss on drying | ≤0.5% |
Heavy metals | ≤20ppm |
Enantionmer | Impurity A: ≤0.4% |
Residual solvent | Ethanol: ≤5000ppm Ethyl acetate: ≤5000ppm Acetone: ≤5000ppm N,N-Dimethylformamide: ≤880ppm Methylene chloride: ≤600ppm Benzene: ≤2ppm |
Related substance | Impurity B: ≤0.10% Impurity D: ≤0.10% Impurity E: ≤0.10% Impurity F: ≤0.10% Impurity G: ≤0.10% Impurity H: ≤0.10% Impurity I: ≤0.10% Impurity J: ≤0.10% RVB-4-NJSH: ≤0.10% RVB-ZA: ≤0.10% RVB-BAM: ≤0.10% RVB-ZC: ≤0.10% RVB-HBY: ≤75ppm Any other unknown impurity: ≤0.10% Total impurity: ≤0.3% |
Particle size distribution | D10:/ D50:/ D90:/ |
Assay (anhydrous substance) | 98.0-102.0 |