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Item Details
Product Description
Product Name: Lamivudine
Synonyms:
4-AMINO-1-((2R,5S)-2-HYDROXYMETHYL-[1,3]OXATHIOLAN-5-YL)-1H-PYRIMIDIN-2-ONE
CAS: 134678-17-4
Molecular Formula: C8H11N3O3S
Molecular Weight: 229.25
USP
Specification:
ASSAY ITEMS | SPECIFICATION(USP) |
Appearance | White to off-white crystalline powder |
Solubility | Soluble in water, sparingly soluble in ethanol, practically insoluble in ethyl acetate |
Light Absorption | Not more than 0.0015 (440nm, 100px 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 Lamivudine 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% | |
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 | not more than 0.6% |
HPLC Assay (Anhydrous basis) | Not less than 98.0% and not more than 102.0% |
Use: Anti-Aids API
Lamivudine is a potent nucleoside analog reverse transcriptase inhibitor (nRTI).It is marketed by GlaxoSmithKline with the brand names Zeffix, Heptovir, Epivir and Epivir-HBV. Lamivudine has been used for treatment of chronic hepatitis B at a lower dose than for treatment of HIV. It improves the seroconversion of e-antigen positive hepatitis B and also improves histology staging of the liver. Long term use of lamivudine unfortunately leads to emergence of a resistant hepatitis B virus (YMDD) mutant. Despite this, lamivudine is still used widely as it is well tolerated.
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