Description

Sofosbuvir Impurity B CAS NO 1496552-51-2 is a high-purity reference standard used for the analytical characterization and quality control of the antiviral active pharmaceutical ingredient (API) Sofosbuvir. This compound is critical for ensuring the safety and efficacy of pharmaceutical formulations by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams involved in the development and manufacturing of hepatitis C therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sofosbuvir Impurity B in drug substance and drug product testing.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods such as HPLC, UPLC, and LC-MS in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity profiles and ensure Sofosbuvir API and finished products meet stringent pharmacopeial (USP, EP) specifications.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research and Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this specific impurity during Sofosbuvir synthesis.

Basic Information

Product Name	Sofosbuvir Impurity B
CAS No.	1496552-51-2
Molecular Formula	C22H29FN3O9P
Molecular Weight	529.46 g/mol
Synonyms	PSI-6206; GS-331007 Impurity; (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine-5'-(phenyl methoxy-L-alaninyl) phosphate impurity; Sofosbuvir Related Compound B; GS-7977 Impurity B; 5'-O-[(2S)-2-[[(S)-(Phenoxy)phosphinyl]amino]propanoyl]-2'-deoxy-2'-fluoro-2'-C-methyluridine; 1-[[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-oxido-phosphoryl]oxyethyl (2S)-2-aminopropanoate
EINECS	Contact for details

Quality Control

Our Sofosbuvir Impurity B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance profiling, and structural confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.

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 should be handled 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)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 2.0%
Water Content (KF)	≤ 5.0%
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.