| Customization: | Available |
|---|---|
| Function: | Pharmaceutical Medicine |
| Certification: | GMP, FDA, ISO |
|
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| Items | Standards | Results |
| Appearance | An off-white to yellow powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Sparing soluble in Potassium Chloride aqueous solution, practically insoluble in Potassium biphthalate aqueous solution,practically insoluble in Water. | Complies |
| Water Content | ≤1.00% | 0.85% |
| Heavy Metals | ≤20ppm | Complies |
| Residue on Ignition | ≤0.50% | 0.08% |
| Related Substances | Any single impurity: ≤0.50% | 0.38% |
| Total impurities: ≤1.00% | 0.62% | |
| Assay (HPLC basis on drying) |
99.0%~101.0% | 99.45% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
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