| I tems | S tandards | R esults |
| C haracteristics | White or pale yellow crystall ine powder | Complies |
| I dentification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Soluble in ethanol and dimethyl sulfoxide,almost insoluble in ethanol, hexane, ethyl acetate and water | Complies |
| Specific Rotation | -75 ° ~ -88 ° | -83 ° |
| Water Content | 9.0% ~ 12.0% | 9.8% |
| Crystallinity | Meets the requirements | Complies |
| pH | 2.6 ~ 4.1 | 3.6 |
| Related Substances | Any individual impurity : ≤ 1.00% | 0.45% |
| Total Impurities : ≤ 2.00% | 0.98% | |
|
A
ssay
(HPLC basis on drying) |
95.0% ~ 103.0% | 99.90% |
| Reference Standard | USP35 Standard | |
| Conclusion | The product complie d to USP35 standard . | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |