CAS No:134678-17-4
Shelf life:2 years
The detailed specifications are as below:
| Items | Standard |
| Description | A white or off-white crystall powder |
| Solubility | Soluble in water |
| Identification | |
| 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. |
| By IR | The infrared absorption of sample should exhibit maxima only at the same wavelengths as that of standard. |
| Water by KF | Not more than 0.2% |
| Melting range | Between 174.0℃ and 178.0℃ |
| Absorptivity | Not more than 0.0015 |
| Related substances | |
| Lamivudine-carboxylic acid | Not more than 0.3% |
| Lamivudine diastereomer | Not more than 0.2% |
| Salicylic acid | Not more than 0.1% |
| Any other individual impurity | Not more than 0.1% |
| Total impurities | Not more than 0.6% |
| Limit of Lamivudine Enantiomer | Not more than 0.3% |
| Assay | Between 98.0% and 102.0% on anhydrous and solvent-free basis. |
| Limit of residual solvents | |
| Alcohol | Not more than 0.2% |
| Isopropyl acetate | Not more than 0.2% |
| Methanol | Not more than 0.1% |
| Triethylamine | Not more than 0.1% |
| Isopropyl alcohol* | Not more than 0.5% |
| Ethyl acetate* | Not more than 0.5% |
| Toluene* | Not more than 0.089% |
| Dichloromethane* | Not mote than 0.06% |
| Normal hexane* | Not more than 0.029% |
| DMF* | Not more than 0.088% |
| Total residual solvents | Not more than 0.3% |
* The solvents are used in the manufacturing process of Lamivudine besides those listed in usp42