China 99% Assay High Purity Solifenacin Succinate Pharmaceutical Chemical Powder with CAS 242478-38-2, Find details about China Solifenacin Succinate, Chemicals Solifenacin Succinate from 99% Assay High Purity Solifenacin Succinate Pharmaceutical Chemical Powder with CAS 242478-38-2
Batch No. | HF161203 | Quantity | 15.6kgs |
Mfg. Date | Dec. 03, 2016 | Package | As required |
Rep. Date | Dec. 06, 2016 | Exp. Date | Dec. 02, 2018 |
Items | Standards | Results | |
Appearance | White or off-white crystalline powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Freely soluble in acetic acid, water, methanol, dimethylsulfoxide | Complies | |
Melting Point | 144ºC~150ºC | 146.0ºC~147.5ºC | |
Specific Optical Rotation | +88.0º~+94.0º | +90.2 | |
Loss on Drying | ≤0.50% | 0.06% | |
Heavy Metals | ≤20ppm | Complies | |
Residue on Ignition | ≤0.10% | 0.03% | |
3-Quinuclidinol | ≤0.20% | Complies | |
Succinate Content | 23.5%~25.5% | 24.7% | |
Optical Isomer | Diastereoisomer RS: ≤0.15% | ND | |
Diastereoisomer SS: ≤0.15% | ND | ||
Diastereoisomer RR: ≤0.20% | ND | ||
Residual Solvent | Acetone: ≤5000ppm | ND | |
Dichloromethane: ≤600ppm | ND | ||
Toulene: ≤890ppm | ND | ||
Di isopropyl ether: ≤500ppm | ND | ||
Dimethyl formamide: ≤880ppm | ND | ||
Related Substances | Any single impurity: ≤0.10% | 0.02% | |
Total impurities: ≤0.50% | 0.05% | ||
Assay (HPLC basis on drying) | 98.0%~102.0% | 99.92% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |