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  • COA
Produk Naam Tenofovir Disoproxil Fumarate
CAS 202138-50-9
Voorkoms Wit kristallyne poeier
Molekulêre formule C23H34N5O14P
Molekulêre gewig 635.52
Toets 98%

Tenofovir Disoproxil Fumarate (a prodrug of tenofovir), belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs), Tenofovir Disoproxil Fumarate block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people. In vivo tenofovir disoproxil fumarate is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate

Tenofovir disoproxil is an antiretroviral medication used to prevent and treat HIV/AIDS and to treat chronic hepatitis B. The active substance is tenofovir, while tenofovir disoproxil is a prodrug that is used because of its better absorption in the gut.

The drug is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system. It is marketed by Gilead Sciences under the trade name Viread(as the fumarate, TDF). As of 2015 the cost for a typical month of medication in the United States is more than 200 USD.

Items Spesifikasies Resultate
Voorkoms A White to off white crystalline powder Wit kristallyne poeier
Oplosbaarheid Freely soluble in DMF and in methanol,sparingly soluble in water Conform
Identifikasie A). By IR: Positive Conform
B). By HPLC: Positive Conform
Residu by ontsteking 0.2% maks complies
Water(By K.F) 1.0% maks 0.4%
Heavy metals 20ppm max Conform
Related Substance
(deur HPLC)
a (Tenofovir): 0.15% maks Nie bespeur nie
b (Adenine): 0.15% maks Nie bespeur nie
c (Tenofovir isoproxil monoester): 1.0% maks 0.29%
d (Tenofovir Disoproxil ethyl ester):0.15 maks Nie bespeur nie
e (Tenofovir isopropyl isoproxil ): 0.3% maks Nie bespeur nie
f (Tenofovir Disoproxil carbamate):0.15% maks Nie bespeur nie
g (Tenofovir Disoproxil Dimer):0.15% Nie bespeur nie
Any Individual unspecified impuriy:0.1% 0.09%
Total impurity: 2.0% maks 0.40%
Enantiomeric Purity 1.0% maks Nie bespeur nie
Tenofovir Disoproxil Related compound B 5PPM max Nie bespeur nie
Fumaric Acid 17.5~19.0% 18.03%
Residual solvents Etanol: 5000ug/g max 1159ug/g
Isopropyl alcohol: 5000ug/g max 1077ug/g
Methylene chloride: 600ug/g max Nie bespeur nie
NMP: 530ug/g max Nie bespeur nie
Toets (on anhydrous basis) 98.0% aan 102.0% 99.25%
Afsluiting Comply with USP34

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