Description

Sofosbuvir Metabolites Gs566500 is a key reference standard and synthetic intermediate in the development and quality control of antiviral pharmaceuticals. This compound is critical for ensuring the purity, potency, and safety of active pharmaceutical ingredients (APIs) targeting hepatitis C virus (HCV). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug development, metabolic studies, and rigorous quality assurance testing.

Application

• Pharmaceutical Reference Standard: Used as a primary standard for the quantitative and qualitative analysis of Sofosbuvir and its related substances in drug substances and finished products.
• Metabolite Research: Essential for in-vitro and in-vivo studies to understand the pharmacokinetic profile and metabolic pathways of Sofosbuvir.
• Impurity Profiling: Critical for identifying, characterizing, and controlling process-related impurities and degradation products in API manufacturing, ensuring compliance with ICH guidelines.
• Method Development & Validation: Serves as a critical component in developing and validating robust analytical methods, including HPLC, LC-MS, and UPLC.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance.
• Stability Studies: Used as a marker to assess the stability of Sofosbuvir formulations under various storage conditions.

Basic Information

Item	Detail
Product Name	Sofosbuvir Metabolites Gs566500
CAS No.	1233335-78-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	GS-566500; PSI-6206; Metabolite GS-566500; 2'-Deoxy-2'-α-fluoro-β-C-methyluridine-5'-triphosphate analog; GS566500; Sofosbuvir related compound; GS-331007 precursor
EINECS	Contact for details

Quality Control

Our Sofosbuvir Metabolites Gs566500 is manufactured under strict quality systems suitable for pharmaceutical research and development. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS. Certificates of Analysis (COA) with detailed chromatographic data are provided to ensure traceability and compliance with your internal and regulatory standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.