Tenofovir Impurities

General Information

Tenofovir Impurities and Tenofovir 

Daicel Pharma synthesizes high-quality Tenofovir impurities like (S)-Tenofovir Mono Hydrate, 9-(2-Hydroxypropyl)Adenine, Diethyl-p-toluene sulfonyloxymethyl phosphonate, Hydroxy methyl Tenofovir Disoproxil, and more, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Tenofovir. Moreover, Daicel Pharma offers custom synthesis of Tenofovir impurities and delivers them globally.

Tenofovir [CAS: 147127-20-6] is a medicine that treats HIV in combination with other drugs. In addition, it treats hepatitis B virus (HBV) infection. It is an acyclic nucleotide analog of adenosine.

Tenofovir: Use and Commercial Availability  

Tenofovir treats several viral infections like HIV, herpes simplex virus-2, and hepatitis B virus. It is available orally in two forms, Tenofovir alafenamide, and Tenofovir disoproxil. Tenofovir is a first-line medication for acquired immune deficiency syndrome and chronic hepatitis B infection. It is an active ingredient in many drugs, such as Viread, Truvada, Atripla, Biktarvy, Cimduo, Complera, etc.

Tenofovir Structure and Mechanism of Action

The chemical name of Tenofovir is ([[(2R)-1-(6-Amino-9H-purin-9-yl)propan-2-yl]oxy]methyl)phosphonic acid. Its chemical formula is C₉H₁₄N₅O₄P, and its molecular weight is approximately 287.21 g/mol.

Tenofovir diphosphate inhibits HIV reverse transcriptase activity by competing with deoxyadenosine 5’-triphosphate and incorporating it into DNA.

Tenofovir Impurities and Synthesis

Impurities may arise during the production^1,2 of Tenofovir which can be harmful and require strict monitoring and control. These impurities are influenced by factors, reaction conditions, storage conditions, and the quality of raw materials used during manufacturing. Thus, it is essential to ensure that appropriate quality control measures are in place throughout the production process to guarantee the purity and safety of the final product.

Daicel provides a Certificate of Analysis (CoA) for Tenofovir impurity standards, including (S)-Tenofovir MonoHydrate, 9-(2-Hydroxypropyl)Adenine, Diethyl-p-toluene sulfonyloxymethyl phosphonate, Hydroxy methyl Tenofovir Disoproxil, and more. The CoA is issued from a cGMP-compliant analytical facility and contains complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity³. Additional characterization data, such as 13C-DEPT and CHN, can be provided upon request. Daicel can also prepare any unknown Tenofovir impurity or degradation product. We give a complete characterization report on delivery.