General Information

Adefovir Impurities and Adefovir

Daicel Pharma synthesizes high-quality Adefovir impurities like Adefovir dipivoxil Impurity-1, Adefovir Dipivoxil Dimer, Adefovier Dipivoxil Impurity-5, Adefovir Tripivoxil Dimer Diethylamine salt, and Adefovir Dipivoxil N6-Hydroxy methyl impurity, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Adefovir. Moreover, Daicel Pharma offers custom synthesis of Adefovir impurities and delivers them globally.

Adefovir [CAS: 106941-25-7] is an analog of Adenosine inhibiting the reverse transcriptase enzyme. It has antiviral activity against the hepatitis B virus, herpes virus, and human immunodeficiency virus (HIV). Adefovir dipivoxil is a prodrug of Adefovir that treats chronic hepatitis B alone or in combination with other medicines.

Adefovir: Use and Commercial Availability  

Adefovir is an acyclic analog of Adenosine. It treats chronic hepatitis B either alone or in combination with other drugs. It is available in the market under Hepsera and Adefovir Dipivoxil. Adefovir inhibits the replication of the hepatitis B virus, reducing the amount of virus in the body and slowing down the progression of the disease.

Adefovir Structure and Mechanism of Action

The chemical name of Adefovir is 2-(6-Aminopurin-9-yl)ethoxymethylphosphonic acid. Its chemical formula is C₈H₁₂N₅O₄P, and its molecular weight is approximately 273.19 g/mol.

Adefovir is converted to its metabolite adefovir diphosphate by adenylate kinase through phosphorylation reactions. It inhibits viral DNA polymerase.

Adefovir Impurities and Synthesis

Like other drugs, Adefovir may contain impurities that can affect its purity, potency, and safety. Impurities in Adefovir arise from various sources, including the starting materials, synthetic processess^1,2, and storage conditions. The common impurities in Adefovir include related substances, residual solvents, and heavy metals. The control of Adefovir impurities is necessary to ensure its quality, safety, and efficacy, as well as to comply with regulatory requirements.

Daicel provides a Certificate of Analysis (CoA) for Adefovir impurity standards, including Adefovir dipivoxil Impurity-1, Adefovir Dipivoxil Dimer, Adefovier Dipivoxil Impurity-5, Adefovir Tripivoxil Dimer Diethylamine salt, and Adefovir Dipivoxil N6-Hydroxy methyl impurity. 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 Adefovir impurity or degradation product. We give a complete characterization report on delivery.