Customization: | Available |
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Function: | Anti-Rheumatism |
Certification: | GMP, FDA, ISO |
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Items | Standards | Results |
Appearance | Light yellow to yellow slightly hygroscopic. | Complies |
Identification | By IR | Complies |
The filtrate gives reaction of chlorides. | Complies | |
Solubility | Sparingly soluble in water,slightly soluble in ethanol(96 percent),practically insoluble in acetone. | Complies |
pH | 3.9~4.6 | 4.47 |
Clarity | Not more than 2 turbidity standard solution turbidity | Complies |
Specific Optical Rotation | -125º~-138º | -130.12º |
Water Content | ≤ 4.50% | 0.40% |
Heavy Metals | ≤ 10ppm | Complies |
Sulphated Ash | ≤ 0.10% | 0.03% |
Residual Solvents | Methylene Chloride: ≤ 600ppm | ND |
Ethanol: ≤ 5000ppm | 71ppm | |
Acetic Acid: ≤ 5000ppm | 27ppm | |
Related Substance | Impurity A: ≤0.10% | 0.04% |
Impurity B: ≤0.10% | ND | |
Impurity C: ≤0.10% | ND | |
Impurity D: ≤0.10% | ND | |
Impurity E: ≤0.10% | ND | |
Unspecified impurities: ≤0.10% | 0.05% | |
Total impurities: ≤0.30% | 0.10% | |
Assay (on the anhydrous basis) | 98.0%~102.0% | 99.88% |
Reference Standard | BP Standard | |
Conclusion | The product complied to BP standard. | |
Storage | Preserve in tight,light-resistant containers in a cool place |