Items | Standards | Results |
Appearance | White or off-white crystalline powder | Complies |
Identification | By IR | Complies |
By HPLC | Complies | |
Solubility | Sparingly soluble in methanol, slightly soluble in acetonitrile and ethanol, very slightly soluble in water | Complies |
Loss on Drying | ≤ 1.00% | 0.35% |
Heavy Metals | ≤ 20ppm | Complies |
Residue on Ignition | ≤ 0.10% | 0.06% |
Residual Solvents | Ethanol: ≤ 5000ppm | 180ppm |
Dichloromethane: ≤ 600ppm | 3ppm | |
Related Substance | Any single impurity: ≤0.10% | 0.06% |
Total Impurities: ≤1.00% | 0.18% | |
Assay (HPLC basis on drying) | 98.0%~102.0% | 99.96% |
Reference Standard | In-house Standard | |
Conclusion | The product complied to In-house standard. | |
Storage | Preserve in tight,light-resistant containers in a cool place |