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Lamivudine (3TC)
DATE: 2010-6-13  BROWSE: [7840]

CAS No.: 
        Molecular formula:
134678-17-4
    C8H11N3 O3 S

  SPECIFICATIONS SHEET

 

Color and Appearance:
 White to off –white solid
 
Limit of Lamivudine Enantiomer
 Not more than 0.30%
Melting Point:
174℃-180℃
 
Solubility
Soluble in water
 
Light absorption
 
Absorptivity at 440nm should be not more than 0.0015
 
Melting Range
174℃-180℃
 Water (by KF):
 
≤100.020%
Heavy Metal
≤ 0.002%
Residue on ignition
≤0.20% w/w
Any peak at relative retention time of about 0.4(Carboxylic acid)
≤0.30%
Any peak at relative retention time of about 0.9 (Lamivudine diastereomer)
≤0.20%
Salicylic acid
≤0.10%
Any other individual impurity
≤0.10%
Total impurities
≤0.60%
Assay (by HPLC)
Not less than 98.0 % and not more than 102.0 % of C8H11N3O3S, calculated on the anhydrous and solvent free basis.
Methanol
≤500 ppm
Ethyl alcohol
≤500 ppm
Isopropyl alcohol
≤3000 ppm
Ethyl acetate
≤500 ppm
Triethyl amine
≤200 ppm
Toluene
≤100 ppm
Total residual solvents
≤0.30%
Specific optical rotation         (at 20°C on anhydrous basis)
–120° ~ –145°
Packing:
Each net in 25kgs drum
Standard:
USP29

 

Lamivudine is nucleoside antiviral drugs, in vitro and experimental infection in animals the hepatitis B virus (HBV) have a strong inhibition. Lamivudine in HBV infection and normal cell metabolism within three phosphate production lamivudine, which is the active form of lamivudine, both of the HBV polymerase inhibitor, this polymerase is the substrate. Lamivudine three phosphate incorporation into viral DNA chain, blocking viral DNA synthesis. Lamivudine three phosphate do not interfere with the normal cell metabolism nucleoside, it mammalian DNA polymerase α and β weak inhibition of DNA content in mammalian cells has almost no effect. Lamivudine on mitochondrial structure and function of DNA content no obvious toxicity. For the majority of patients with hepatitis B serum HBV DNA test results show that lamivudine can rapidly inhibit the replication of HBV and its continuing effect on the entire treatment process. While serum transaminase to normal, long-term use can significantly improve liver necrosis and inflammatory changes to reduce or stop the progress of liver fibrosis.

 

LAMIVUDINE (3TC)

 2(R) - (HYDROXY METHYL) -5(S) CYTOSIN -1’-YL- 1,3- OXATHIOLANE

(2R, cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one

CAS No. [134678-17-4]

Molecular Formula: C8 H11 N3 O3 S

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