Description

Sofosbuvir Impurity 41 is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient Sofosbuvir. This compound is essential for pharmaceutical manufacturers and research laboratories to identify, quantify, and monitor this specific impurity, ensuring the safety, efficacy, and regulatory compliance of antiviral drug products. It is primarily used by quality control (QC) and research & development (R&D) teams in the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Sofosbuvir Impurity 41 in drug substance and drug product testing.
• Method Development and Validation: Used in the development, optimization, and validation of analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) and pharmacopeial (USP, EP) specified limits.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this specific impurity during Sofosbuvir manufacturing.

Basic Information

Product Name	Sofosbuvir Impurity 41
CAS No.	874638-86-5
Molecular Formula	C₂₂H₂₉FN₃O₉P
Molecular Weight	529.45 g/mol
Synonyms	PSI-6206 Impurity; GS-331007 Impurity (related); Isopropyl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate; Sofosbuvir Related Compound 41; 1-(2-Deoxy-2-fluoro-2-methyl-β-D-erythro-pentofuranosyl)-2,4(1H,3H)-pyrimidinedione 5'-(phenyl hydrogen ((1S)-1-methylethoxycarbonyl)methyl)phosphoramidate; GS-9669 Impurity (process-related); Hepatitis C Virus (HCV) NS5B Polymerase Inhibitor Impurity.
EINECS	Contact for details

Quality Control

Our Sofosbuvir Impurity 41 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.