Lamivudine CAS: 134678-17-4

Product Detail

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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