Sofosbuvir Impurities and Sofosbuvir
Daicel Pharma offers a comprehensive range of exclusive Sofosbuvir impurities such as D-Alanine Sofosbuvir, Sofosbuvir (R)-Phosphate, Sofosbuvir D-alaninate R, S Isomer, Sofosbuvir Isomer 3, Sofosbuvir Impurity, and more. These impurities are critical in determining the active pharmaceutical ingredient Sofosbuvir’s quality, stability, and biological safety. Additionally, Daicel Pharma can synthesize Sofosbuvir impurities according to precise customer specifications while guaranteeing worldwide delivery.
Sofosbuvir [CAS: 1190307-88-0] is an orally administered nucleoside analog prescribed with other antiviral medications It treats chronic Hepatitis C Virus (HCV) infection in patients with HCV genotypes 1,2, 3,4, 5, 6. It is also effective in treating patients co-infected with HCV and HIV.
Sofosbuvir: Use and Commercial Availability
Sofosbuvir is a widely used antiviral medication available for treating chronic hepatitis C virus (HCV) infections. It combines with other antiviral drugs as a comprehensive therapy regimen. Sofosbuvir is administered orally, making it convenient for patients. It has been proven highly effective in achieving sustained virologic response, improving patient outcomes.
Sofosbuvir is available under Sovaldi, which contains the active ingredient, Sofosbuvir.
Sofosbuvir Structure and Mechanism of Action
The chemical name of Sofosbuvir is N-[[P(S),2′R]-2′-deoxy-2′-fluoro-2′-methyl-P-phenyl-5′-uridylyl]- L-Alanine 1-methylethyl ester. Its chemical formula is C22H29FN3O9P, and its molecular weight is approximately 529.5 g/mol.
Sofosbuvir prevents the HCV NS5B RNA-dependent RNA polymerase that causes viral replication.
Sofosbuvir Impurities and Synthesis
During the synthesis1 and storage of Sofosbuvir, impurities can arise, including related substances, degradation products, and residual solvents. It is essential to carefully monitor and control these impurities to ensure the medication’s safety, efficacy, and overall quality.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Sofosbuvir impurity standards such as D-Alanine Sofosbuvir, Sofosbuvir (R)-Phosphate, Sofosbuvir D-alaninate R, S Isomer, Sofosbuvir Isomer 3, Sofosbuvir Impurity, and more. These impurities form in compliance with current Good Manufacturing Practices (cGMP). The CoA includes detailed characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2, providing a thorough understanding of the impurity profile. Upon request, Daicel can also provide 13C-DEPT data for further characterization.
Furthermore, Daicel Pharma possesses the technical expertise to synthesize any unknown impurities or degradation products of Sofosbuvir. We also offer labeled compounds. For bioanalytical research and Bioavailability/Bioequivalence (BA/BE) studies, Daicel Pharma supplies Sofosbuvir-D6, a highly pure deuterated-labeled standard of Sofosbuvir.
- Sofia, Michael J.; Bao, Donghui; Chang, Wonsuk; Du, Jinfa; Nagarathnam, Dhanapalan; Rachakonda, Suguna; Reddy, P. Ganapati; Ross, Bruce S.; Wang, Peiyuan; Zhang, Hai-Ren; et al, Discovery of a β-D-2'-Deoxy-2'-α-fluoro-2'-β-C-methyluridine Nucleotide Prodrug (PSI-7977) for the Treatment of Hepatitis C Virus, Journal of Medicinal Chemistry, Volume: 53, Issue: 19, Pages: 7202-7218, 2010
- Rezk, Mamdouh R.; Basalious, Emad B.; Karim, Iman A., Development of a sensitive UPLC-ESI-MS/MS method for quantification of sofosbuvir and its metabolite, GS-331007, in human plasma: Application to a bioequivalence study, Journal of Pharmaceutical and Biomedical Analysis, Volume: 114, Pages: 97-104, 2015
Frequently Asked Questions
Sofosbuvir impurities can arise from various sources, including starting materials, reagents, or by-products formed during the synthetic process.
Analytical Methods such as Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) can detect impurities in Sofosbuvir.
Impurities in Sofosbuvir can impact patient safety. Depending on their nature and concentration, contaminants can cause adverse effects or reduce the efficacy of the medication.
Acetonitrile helps achieve optimal solubility and separation of Sofosbuvir impurities.
Sofosbuvir impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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