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Lamivudine or Lamivudin BP EP USP CAS 134678-17-4 
Product Name: Lamivudine
Synonyms: Lamivudin
CAS Number: 134678-17-4
Characteristics: White or off white crystalline powder
Assay: 98%~102%, anhydrous and solvent-free basis
Formula: C8H11N3O3S
Package: 1Kg/Drum
Usage: Lamivudine (Lamivudin) is used to produce preparations that can cure HIV infections. It belongs to nucleoside reverse transcriptase inhibitors (NRTIs).
Certificate of Analysis—Lamivudine
Testing Item |
Standard |
Result |
Appearance |
White or off white crystalline powder |
Complies |
Solubility |
Soluble in water, sparingly soluble in methanol. |
Complies |
Identification A by HPLC |
The retention time of the major peak corresponds to that of system suitability solution, as obtained in the test for limit of Lamivudine Enantiomer. |
Complies |
Identification B by IR |
The Infrared absorption should exhibit maxima only at the same wavelengths as the standard |
Complies |
Melting Point |
174°C ~ 178°C |
176.4°C ~ 177.4°C |
Water (KF) |
≤ 0.2% |
0.05% |
Specific Optical Rotation |
-97° ~ -99° |
-98° |
Residual on Ignition |
≤ 0.1% |
0.02% |
Heavy Metals |
≤ 20ppm |
< 20ppm |
Absorptivity |
≤ 0.0015 |
0.0002 |
|
Related Substances a). Cytosine b). Uracil c). RRT0.4 d). RRT0.9 e). Salicylic Acid f). Individual impurity g). Total Impurities |
≤ 0.1% ≤ 0.1% ≤ 0.3% ≤ 0.2% ≤ 0.1% ≤ 0.1% ≤ 0.6% |
0.007% Not Detected 0.09% 0.05% Not Detected 0.02% 0.17% |
|
Enantiomeric Impurity (HPLC) |
≤ 0.3% |
Not Detected |
|
Limit of Residual Solvent Alcohol Isopropyl Acetate Methanol Triethylamine Isopropyl Alcohol Ethyl Acetate Toluene Dichloromethane Normal Hexane Total Residual Solvents |
≤ 0.2% ≤ 0.2% ≤ 0.1% ≤ 0.1% ≤ 0.5% ≤ 0.5% ≤ 0.089% ≤ 0.06% ≤ 0.029% ≤ 0.3% |
ND ND ND ND 0.113% ND ND ND ND 0.113% |
Content (Lamivudine) |
98%~102%, anhydrous and solvent-free basis |
99.9% |
