ASSAY ITEMS

SPECIFICATION

Appearance

White or almost white crystalline powder

Solubility

Soluble in water

Light Absorption

Not more than 0.0015

(440nm, 4cm cell, 50mg/ml)

Identification

A) The IR Spectrum of test sample corresponds to the standard IR spectrum of Lamivudine

B) The retention time of the major peak in the chromatogram of the test solution corresponds to that in chromatogram of the reference solution, as obtained in the test of Limit of Lamivudine enantiomer.                                    

Water

Not more than 0.2%

Limit of Enantiomer

Not more than 0.3%

Residual

Solvents

 Ethanol is not more than 0.2%

Triethylamine (TEA) is not more than 0.1%

Dichloromethane is not more than 0.06%

Toluene is not more than 0.089%

N,N-Dimethylformamide is not more than 0.088%

n-Hexane is not more than 0.029%

Dehydrated alcohol is not more than 0.2%

Isopropyl acetate is not more than 0.2%

Methanol is not more than 0.1%

Triethylamine is not more than 0.1%

Total residual solvents not more than 0.3%

Chromatographic Purity

Salicylic acid is not more than 0.10%

Relative retention time at about 0.4 impurity is not more than 0.3%

Relative retention time at about 0.9 impurity is not more than 0.2%

Any other individual impurity is not more than 0.1%

Total impurities is not more than 0.6%

Assay (dry basis)

Not less than 98.0% and not more than 102.0%