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| Items | Specification | Analysis Result | |
|---|---|---|---|
| Appearance | White to light yellow crystalline powder | Conform | |
| Identification | 1. The retention times of the major peaks in the chromatogram of the assay preparation correspond to those of the Standard preparation obtained in the assay | Conform | |
| 2. The IR absorption spectrum of the substance to be examined corresponds to that of the reference standard. | Conform | ||
| Specific Rotation | -75°~-88° | -84° | |
| Crystallinity | Meets the USP test requirements | Conform | |
| PH | 2.6~4.1 | 3.6 | |
| Water Content | 9.0%~12.0% | 10.4 | |
| Residue of ignition | Not more than 0.1% | Conform | |
| Heavy Metals | Not more than 20ppm | Conform | |
| Chromatographic purity | Meets the USP test requirements | Conform | |
| Assay (anhydrous) | 95.0%~103.0% | 0.998 | |
| Related Impurities | Individual impurities | Not more than1.00% | 0.003 |
| Total impurities | Not more than2.00% | 0.008 | |