- PRODUCT NAME:Emtricitabine
Emtricitabine is an antiviral medication used in the treatment of human immunodeficiency virus (HIV) infection and as a component of pre-exposure prophylaxis (PrEP) to prevent HIV transmission. It belongs to the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs), which work by interfering with the replication of the virus.
Emtricitabine is available in oral tablet form and is often prescribed as part of combination therapy for HIV or used in combination with other medications for PrEP.
Key uses and benefits of Emtricitabine:
1:HIV Treatment: Emtricitabine, in combination with other antiretroviral medications, is used to suppress HIV replication, reduce the viral load in the blood, and slow down the progression of the disease. This helps improve the patient's immune system and reduces the risk of developing acquired immunodeficiency syndrome (AIDS).
2:HIV Prevention (PrEP): In certain populations at high risk of HIV transmission, such as individuals with an HIV-positive partner or individuals engaging in high-risk sexual activities, Emtricitabine, in combination with another antiviral medication called tenofovir disoproxil fumarate, is used as pre-exposure prophylaxis (PrEP) to prevent HIV infection when taken regularly.
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Batch No. |
Date of Manufacture |
Date of Retest |
Date of Analysis |
Package |
Quantity |
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2100026012 |
Nov-05-2021 |
Nov-04-2023 |
Nov-15-2021 |
20kg/drum |
75kg |
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ASSAY ITEMS |
SPECIFICATION |
TEST RESULTS |
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Description |
White to off-white powder |
White powder |
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Solubility |
Freely soluble in methanol and water, practically insoluble in dichloromethane. |
Complies |
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Identification |
A:By IR The infrared absorption spectrum of the finely ground sample in KBr dispersion compressed into a disc should exhibit maxima only at the same wavelengths as that of a similar preparation of Emtricitabine reference standard. |
Complies |
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B: By HPLC The retention time of the major peak in the chromatogram of the test solution corresponds to that in chromatogram of the standard solution, as obtained in the test for Assay. |
Complies |
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Loss on Drying |
Not more than 0.5% |
0.2% |
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Residue on Ignition |
Not more than 0.1% |
0.02% |
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Heavy Metals |
Not more than 20ppm |
Complies |
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Specific Optical Rotation |
-105.0°~-115.0° (on dried basis) |
-110.1° |
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Enantiomer and Emtricitabine 5-epimers content by Chiral HPLC |
Emtricitabine Enantiomer Not more than 0.3% |
0.02% |
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Emtricitabine 5-epimers Not more than 0.2% |
0.07% |
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Organic Impurities By HPLC |
Fluorocytosine not more than 0.1% |
0.007% |
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Emtricitabine acid not more than 0.3% |
0.007% |
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Emtricitabine Sulfoxides not more than 0.15% |
0.078% |
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Lamivudine not more than 0.2% |
Not detected |
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Emtricitabine 5-fluorouracil analog not more than 0.2% |
0.01% |
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Emtricitabine menthyl ester not more than 0.1% |
Not detected |
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Any other individual impurity not more than 0.10% |
0.033% |
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Total impurity (including emtricitabine 5-epimers) not more than 0.6% |
0.2% |
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Residual Solvents |
Ethanol is not more than 2000ppm |
0.02% |
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Triethylamine(TEA) is not more than 320ppm |
Not detected |
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Dichloromethane is not more than 600ppm |
Not detected |
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Toluene is not more than 890ppm |
Not detected |
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N,N-Dimethylformamide is not more than 880ppm |
Not detected |
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Acetonitrile is not more than 410ppm |
Not detected |
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n-Propyl alcohol is not more than 3000ppm |
0.02% |
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n-Hexane is not more than 290ppm |
Not detected |
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Assay (on dried basis) |
Not less than 98.0% and not more than 102.0% |
100.2% |
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Conclusion |
Batch No. 2100026012 complies with the specificatlons |
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