Impurity Profile
Lamivudine Enantiomer: Not more than 0.3%
Impurity 1 (0.4 Ret. Time): Not more than 0.3%
Impurity 2 (0.9 Ret. Time): Not more than 0.2%
Salicylic Acid: Not more than 0.1%
Individual impurity: Not more than 0.1%
Total impurities: Not more than 0.6%
Water Content (Karl Fisher)
Not more than 0.2%
Absorbance
(440nm): Not more than 0.0015
Melting Point
175 - 179°C
Optical Rotation
-135.0 - -145.0°
Assay
98.0 - 102.0%
Loss on Drying
Not more than 0.5%
Sulfated Ash
Not more than 0.1%
Heavy Metals
Not more than 20ppm
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%
Total Residual Solvents: Not more than 0.3%
