| Customization: | Available |
|---|---|
| Function: | Anti-Viral |
| Certification: | GMP, FDA, ISO |
|
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| Items | Standards | Results |
| Appearance | White or off-white solid powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Reaction of sodium salt | Complies | |
| Solubility | Freely soluble in Water; very sparingly soluble in Ethanol | Complies |
| Polymorphism | Form 1 | Complies |
| pH | 7.0~9.0 | 7.90 |
| Loss on Drying | ≤ 1.00% | 0.08% |
| Heavy Metals | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.05% |
| Residual Solvents | Ethanol: ≤5000 ppm | 410ppm |
| Ethyl acetate:≤5000 ppm | ND | |
| Isopropanol:≤5000 ppm | ND | |
| Related Substance | Any Single Unknown Impurity: ≤ 0.10% | 0.09% |
| Total Impurities: ≤ 0.50% | 0.21% | |
| Enantisomer | ≤ 0.15% | ND |
| Purity(by HPLC) | ≥99.0% | 99.79% |
| Bulk density | ≤ 1.00 | Complies |
| Tapped density | ≤ 1.00 | Complies |
| Particle Size | D90 ≤180μm | Complies |
| Bacterial Endotoxin Limit | ≤ 1.1 IU/mg | Complies |
| 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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