Description

Sofosbuvir Metabolites CAS NO 1859162-80-3 are key chemical intermediates and reference standards critical for the research, development, and quality control of antiviral pharmaceuticals. These metabolites are essential for studying the pharmacokinetics, metabolic pathways, and efficacy of Sofosbuvir, a cornerstone medication in the treatment of chronic Hepatitis C virus (HCV) infection. They are primarily required by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers engaged in the production of generic antiviral drugs and novel therapeutic formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Sofosbuvir and its impurities in drug substances and finished products.
• Metabolite Profiling & Pharmacokinetic Studies: Essential for in-vitro and in-vivo studies to identify and quantify active metabolites, understanding drug metabolism and bioavailability.
• Process Development & Validation: Serves as a critical intermediate in the development and optimization of synthetic routes for Sofosbuvir and related antiviral compounds.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, and GC-MS methods for therapeutic drug monitoring and clinical studies.
• Impurity Identification and Control: Acts as a marker to identify, track, and control process-related impurities and degradation products in accordance with ICH guidelines.
• Generic Drug Development: A vital component for companies demonstrating bioequivalence and meeting regulatory requirements for abbreviated new drug applications (ANDAs).

Basic Information

Item	Details
Product Name	Sofosbuvir Metabolites
CAS No.	1859162-80-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	GS-331007; PSI-6206; GS-331007 (Metabolite of Sofosbuvir); Sofosbuvir Carboxylate; 2'-Deoxy-2'-α-fluoro-β-C-methyluridine-5'-monophosphate; β-D-2'-Deoxy-2'-fluoro-2'-C-methyluridine-5'-monophosphate; PSI-6206 Metabolite; GS-331007 (PSI-6206)
EINECS	Contact for details

Quality Control

Our Sofosbuvir Metabolites are produced under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all critical quality attributes. Our commitment to quality supports compliance with cGMP and ICH Q7 guidelines for active pharmaceutical ingredients (APIs) and key starting materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere (e.g., nitrogen or argon) in a desiccator for long-term storage to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 10 ppm

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