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CAS No:134678-17-4
Shelf life:2 years
The detailed specifications are as below:

DescriptionA white or off-white crystall powder
SolubilitySoluble in water
By HPLCThe 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 IRThe infrared absorption of sample should exhibit maxima only at the same wavelengths as that of standard.
Water by KFNot more than 0.2%
Melting rangeBetween 174.0℃ and 178.0℃
AbsorptivityNot more than 0.0015
Related substances
Lamivudine-carboxylic acidNot more than 0.3%
Lamivudine diastereomerNot more than 0.2%
Salicylic acidNot more than 0.1%
Any other individual impurityNot more than 0.1%
Total impuritiesNot more than 0.6%
Limit of Lamivudine EnantiomerNot more than 0.3%
AssayBetween 98.0% and 102.0% on anhydrous and solvent-free basis.
Limit of residual solvents
AlcoholNot more than 0.2%
Isopropyl acetateNot more than 0.2%
MethanolNot more than 0.1%
TriethylamineNot 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 solventsNot more than 0.3%

* The solvents are used in the manufacturing process of Lamivudine besides those listed in usp42