Description

Sofosbuvir is a direct-acting antiviral nucleotide prodrug inhibitor of the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase. It is a cornerstone active pharmaceutical ingredient (API) in the global fight against chronic hepatitis C infection, enabling highly effective and well-tolerated treatment regimens. This high-purity compound is essential for pharmaceutical manufacturers developing generic and branded antiviral medications targeting HCV genotypes 1, 2, 3, and 4.

Application

• Pharmaceutical API: Primary use as the key active ingredient in the formulation of sofosbuvir tablets (e.g., Sovaldi®).
• Combination Therapy Drug Substance: Used in fixed-dose combination products with other antiviral agents like ledipasvir (Harvoni®), velpatasvir (Epclusa®), and voxilaprevir (Vosevi®).
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions following patent expirations in various markets.
• Research & Development: Serves as a reference standard and starting material in antiviral research, mechanism of action studies, and the development of new therapeutic combinations.
• Clinical Trial Material: Supply of GMP-grade material for pre-clinical and clinical studies of new hepatitis C treatments.

Basic Information

Product Name	Sofosbuvir
CAS No.	1190307-88-0
Molecular Formula	C22H29FN3O9P
Molecular Weight	529.45 g/mol
Synonyms	PSI-7977; GS-7977; Sovaldi (trade name base); (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine 5'-(trihydrogen diphosphate) Phenyl 1-methylethyl-L-alaninate ester; GS 7977; PSI 7977; Sofosbuvir [USAN:INN]; UNII-4S68TZ62NN
EINECS	Contact for details

Quality Control

Our Sofosbuvir is manufactured under strict quality management systems. We provide material that meets or exceeds current pharmacopeial standards, including ICH Q7 GMP guidelines for active pharmaceutical ingredients. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring traceability and regulatory compliance for global pharmaceutical submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.