| Function: | Antiviral |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
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Audited Supplier | Items Tested | Specification | Results |
| Description | A white or off-white crystall powder | A white crystall powder |
| Solubility | Soluble in water. | Meets the requirements |
| Identification | ||
| a). By HPLC | The retention time of the major peak of the sample solution corresponds to that of the system suitability solution, as obtained in the test for limit of Lamivudine Enantiomer. | Meets the requirements |
| b). By IR | The infrared absorption of sample should exhibit maxima only at the same wavelengths as that of standard. | Meets the requirements |
| Water by KF | Not more than 0.2% | 0.07% |
| Melting range | Between 174.0ºC and 178.0ºC | 176.8ºC~177.8ºC |
| Absorptivity | Not more than 0.0015 | 0.0002 |
| Related substances | ||
| Lamivudine-carboxylic acid | Not more than 0.3% | 0.05% |
| Lamivudine diastereomer | Not more than 0.2% | 0.06% |
| Salicylic acid | Not more than 0.1% | Not detected |
| Any other individual impurity | Not more than 0.1% | 0.03% |
| Total impurities | Not more than 0.6% | 0.15% |
| Limit of Lamivudine Enantiomer | Not more than 0.3% | 0.01% |
| Assay | Between 98.0% and 102.0% on anhydrous and solvent-free basis. | 100% |
| Limit of residual solvents | ||
| Alcohol | Not more than 0.2% | Not detected |
| Isopropyl acetate | Not more than 0.2% | Not detected |
| Methanol | Not more than 0.1% | Not detected |
| Triethylamine | Not more than 0.1% | Not detected |
| Isopropyl alcohol* | Not more than 0.5% | 0.156% |
| Ethyl acetate * | Not more than 0.5% | Not detected |
| Toluene* | Not more than 0.089% | Not detected |
| Dichloromethane* | Not more than 0.06% | Not detected |
| Normal hexane * | Not more than 0.029% | Not detected |
| DMF* | Not more than 0.088% | Not detected |
| Total residual solvents | Not more than 0.3% | 0.156% |
| Remark:*The solvents are used in the manufacturing process of lamivudine besides those listed in usp41. | ||
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