| Function: | Pharmaceutical Medicine |
|---|---|
| Certification: | GMP, FDA, ISO |
| Grade Standard: | Medicine Grade |
| Type: | Chemicals |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
|---|
| Customization: |
|---|
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| Items | Standards | Results |
| Appearance | White to slightly yellowish to slightly greenish yellow or brownish powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Freely soluble in Dimethyl Sulphoxide, sparingly soluble in Methanol, very slightly soluble in acetonitrile, practically insoluble in water. | Complies |
| Water Content | 3.0%~5.0% | 3.58% |
| Heavy Metals | ≤ 10ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.07% |
| Chloride Content | 5.6%~6.9% | Complies |
| Residual Solvent | Dichloromethane: ≤ 600ppm | ND |
| Methanol: ≤ 3000ppm | 800ppm | |
| Ethyl acetate: ≤ 5000ppm | ND | |
| Toluene: ≤ 890ppm | ND | |
| Acetone: ≤ 5000ppm | ND | |
| Related Substances | Any single impurity: ≤0.10% | 0.06% |
| Total Impurities: ≤1.00% | 0.07% | |
| Assay (HPLC basis on drying) |
98.00%~102.00% | 99.92% |
| 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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