Description

Sofosbuvir Impurity13 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sofosbuvir. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of antiviral drug formulations. It serves as a key marker for identifying and quantifying process-related impurities during the synthesis and production of Sofosbuvir, a vital medication for treating Hepatitis C virus (HCV) infection.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sofosbuvir Impurity13 in API batches.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Pharmaceutical Research & Development (R&D): Used in stability studies, impurity profiling, and route scouting to optimize the synthesis process of Sofosbuvir.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Quality Assurance/Quality Control (QA/QC): Routine testing of Sofosbuvir API to ensure it meets stringent pharmacopeial standards (e.g., USP, EP) for impurity limits.
• Contract Research Organizations (CROs): Utilized by CROs providing analytical testing and impurity characterization services to the pharmaceutical industry.

Basic Information

Product Name	Sofosbuvir Impurity13
CAS No.	220503-64-0
Molecular Formula	C22H29FN3O9P
Molecular Weight	529.45 g/mol
Synonyms	PSI-6130 Impurity; GS-331007 Impurity; (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine 5'-(trihydrogen diphosphate) P'-[(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)phosphorylamino]propanoate] P-ester; Sofosbuvir Related Compound; Sofosbuvir Process Impurity; 1-((2R,3R,4R,5R)-3-Fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyltetrahydrofuran-2-yl)pyrimidine-2,4(1H,3H)-dione Impurity
EINECS	Contact for details

Quality Control

Our Sofosbuvir Impurity13 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is characterized and confirmed via advanced analytical techniques including HPLC, NMR, and Mass Spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Assay	90.0% - 110.0% (on anhydrous basis)

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