| Customization: | Available |
|---|---|
| Certification: | GMP, FDA, ISO |
| Grade Standard: | Medicine Grade |
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| Items | Standards | Results |
| Appearance | White or off-white crystalline powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Freely soluble in methanol and water,practically insoluble in dichloromethane | Complies |
| Specific Optical Rotation | -105.0°~-115.0° | -108.5° |
| Loss on Drying | ≤ 0.50% | 0.12% |
| Heavy Metals | ≤ 10ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.04% |
| Enantiomer and Emtricitabine 5-epimers content by Chiral HPLC | Emtricitabine Enantiomer: ≤0.30% | 0.01% |
| Emtricitabine 5-epimers: ≤0.20% | 0.03% | |
| Residual Solvent | Ethanol: ≤2000ppm | 450ppm |
| Triethylamine: ≤320ppm | ND | |
| Dichloromethane: ≤600ppm | ND | |
| Toluene: ≤2000ppm | ND | |
| N,N-Dimethylformamide: ≤880ppm | ND | |
| Acetonitrile: ≤410ppm | ND | |
| N-Hexane: ≤290ppm | ND | |
| Related Substances | Fluorocytosine: ≤0.10% | 0.01% |
| Emtricitabine acid: ≤0.30% | 0.02% | |
| Emtricitabine sulfoxides: ≤0.15% | 0.05% | |
| Lamivudine: ≤0.20% | 0.01% | |
| Emtricitabine 5-fluorouracil analog: ≤0.20% | ND | |
| Emtricitabine menthyl ester: ≤0.10% | ND | |
| Any other individual impurity: ≤0.10% | 0.05% | |
| Total impurities: ≤1.00% | 0.23% | |
| Assay | 98.0%~102.0% | 99.98% |
| 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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