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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