- PRODUCT NAME:Tenofovir alafenamide Fumarate
Tenofovir alafenamide fumarate is an antiviral medication used in the treatment of human immunodeficiency virus (HIV) infection and chronic hepatitis B virus (HBV) infection. It belongs to the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs), which work by interfering with the replication of the virus.
Tenofovir alafenamide fumarate is administered orally in the form of tablets and is often prescribed as part of combination therapy for HIV or HBV infection. It is a prodrug, meaning it gets converted to its active form (tenofovir) in the body, where it exerts its antiviral effects.
Key uses and benefits of Tenofovir Alafenamide Fumarate:
1:HIV Treatment: Tenofovir alafenamide fumarate, 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: In certain populations at high risk of HIV transmission, such as individuals with an HIV-positive partner, Tenofovir alafenamide fumarate is used as pre-exposure prophylaxis (PrEP) to prevent HIV infection when taken regularly.
3:Chronic Hepatitis B: For individuals with chronic HBV infection, Tenofovir alafenamide fumarate can help suppress viral replication, improve liver function, and reduce the risk of liver-related complications.
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Batch No. |
Date of Manufacture |
Date of Retest |
Date of Analysis |
Package |
Batch Size |
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2200026091 |
Mar-01-2022 |
Feb-28-2025 |
Mar-05-2022 |
25kg/drum |
246.745kg |
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TEST ITEMS |
SPECIFICATION |
TEST RESULTS |
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Description |
White to off white powder |
White powder |
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Solub i l ity |
Soluble in ethanol, sparingly soluble in water and i sop ropanol. |
Complies |
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Specif ic Optica l Rotation |
-47.0°~-57.0° |
-53.4° |
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Identi fication |
The IR spectrum of test sample is concordant with that of the Tenofovir Alafenamide Fumarate Reference Standard obtained in the similar manner. |
Complies |
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The retention time of the Tenofovir Alafenamide peak in the chromatogram of the test solution corresponds to that in the chromatogram of the reference standard solution, as obtained in the test of assay. |
Complies |
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Melting point |
Initial melting point should be not less than 130℃ |
131℃~132℃ |
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Water |
Not more than 1.0% |
0.08% |
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Diasterepmers |
Not more than 0.50% |
0.11% |
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Organic Impurities |
PMPA is not more than 0.30% |
Below LOD 0.0032% |
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PMPA anhydride is not more than 0.25% |
Below LOQ 0.0106% |
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Monophenyl PMPA is not more than 0.15% |
Below LQQ 0.0105% |
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TA monoacid is not more than 0.15% |
0.016% |
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Phenol is not more than 0.20% |
Not detected |
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Any individual unspecified impurity is not more than 0.10% |
0.037% |
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Total impurities is not more than 1.0% |
0.10% |
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Fumaric acid |
10.4%~11.2% |
10.8% |
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Residue on Ignition |
Not more than 0.10% |
0.030% |
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Residual Solvents |
Isopropanol is not more than 0.40% |
0.33% |
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Acetonitrile is not more than 0.041% |
Not detected |
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Dichloromethane is not more than 0.06% |
Not detected |
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Ethyl acetate is not more than 0.30% |
Not detected |
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Toluene is not more than 0.089% |
Not detected |
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Triethylamine is not more than 0.032% |
Not detected |
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Total residual solvents is not more than 0.50% |
0.33% |
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Assay |
Not less than 98.0%(on anhydrous basis) |
100.1% |
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Conclusion |
Batch No: 2200026091 complies with the specification. |
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