Lamivudine USP Pharmaceutical Pharmaceutical API Antiviral drugs Nucleoside made in china CAS NO.134678-17-4

appearance

white or off- white crystalline powder

identification

ir,hplc conform

light absorption

≤0.0015%

water

≤0.20%

limit of lamivudine enantiomer

≤0.30%

residual solvent

ethanol

≤0.20%

tea:

≤0.10%

dichloromethane

≤0.06%

toluene

≤0.089%

n,n-dimethylformamide

≤0.088%

n-hexane

≤0.029%

total residue solvents

≤0.30%

chromatographic purity by hplc

rrt at about 0.4 impurity

≤0.30%

rrt at about 0.9 impurity

≤0.20%

salicylic acid

≤0.10%

any individual impurity

≤0.10%

total impurity

≤0.60%

assay(hplc)

98.0%~102.0%(anhydrous and solvent-free)