| Customization: | Available |
|---|---|
| Function: | Pharmaceutical Medicine |
| Certification: | GMP, FDA, ISO |
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| Items | Specifications | Results |
| Appearance | White to off-white powder | White powder |
| Identification | H-NMR, MS | Complies |
| Specific optical rotation | -138~143° | -141° |
| Residual Solvents |
Methanol£0.3% | 0.2% |
| Ethanol£0.5% | ND | |
| Acetone£0.5% | ND | |
| Isopropanol£0.5% | 0.06% | |
| Dichloromethanec£0.06% | ND | |
| Methyl tert-butyl ether £0.5% | ND | |
| n-Hexane £0.029% | ND | |
| Ethyl acetate£0.5% | ND | |
| Tetrahydrofuran£0.072% | ND | |
| Toluene£0.089% | ND | |
| DMF£0.088% | ND | |
| Dimethyl Sulfoxide£0.5% | ND | |
| Residue on ignition | £0.5% | 0.1% |
| Water content | £0.5% | 0.03% |
| Heavy metal | £10ppm | Complies |
| Enantiomer | Enantiomer impurity H£0.1% | ND |
| Impurities |
Impurities A£0.1% | ND |
| Impurities B£0.1% | Less than LOQ | |
| Impurities C£0.1% | ND | |
| Impurities D£0.1% | ND | |
| Impurities E£0.1% | ND | |
| Impurities F£0.1% | ND | |
| Impurities G£0.1% | ND | |
| Impurities SM1£0.1% | ND | |
| Impurities SM2£0.1% | ND | |
| Any other unknown Impurities£0.1% | ND | |
| Total impurity ≤0.5 % | ND | |
| Purity(HPLC) | ³99.5% | 99.99% |
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