Listing ID #4246063
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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 |