Description

Sofosbuvir Impurity C 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 ensuring the purity, safety, and efficacy of antiviral drug formulations by serving as a benchmark in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Hepatitis C treatments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Sofosbuvir API batches.
• Method Development and Validation: Crucial for developing, optimizing, and validating stability-indicating HPLC or UPLC methods in analytical laboratories.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines for drug substance impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity formation profiles over time.
• Pharmaceutical Research: Serves as a key intermediate or degradation product for research into the metabolism and degradation pathways of Sofosbuvir.

Basic Information

Product Name	Sofosbuvir Impurity C
CAS No.	1337482-15-1
Molecular Formula	C22H29FN3O9P
Molecular Weight	529.46 g/mol
Synonyms	PSI-6206; GS-331007 Impurity; Sofosbuvir Related Compound C; (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine-5'-(phenyl methoxy-L-alaninyl) phosphate; Uridine, 2'-deoxy-2'-fluoro-2'-C-methyl-, 5'-(phenyl methoxy-L-alaninyl) phosphate, (2'R)-; GS-9669 Impurity; Sofosbuvir EP Impurity C; Sofosbuvir USP Impurity C
EINECS	Contact for details

Quality Control

Our Sofosbuvir Impurity C is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial standards (USP, EP) where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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