Description

Sofosbuvir Impurity M is a high-purity reference standard used for the analytical characterization and quality control of the active pharmaceutical ingredient Sofosbuvir. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry, particularly for antiviral drug production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sofosbuvir Impurity M in drug substances and products.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies & Forced Degradation: Used to monitor the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Sofosbuvir to minimize the formation of this impurity.
• Quality Control & Batch Release Testing: Serves as a system suitability standard and for preparing calibration curves to ensure every batch of Sofosbuvir API meets stringent purity specifications.

Basic Information

Product Name	Sofosbuvir Impurity M
CAS No.	2095551-10-1
Molecular Formula	C22H29FN3O9P
Molecular Weight	529.46 g/mol
Synonyms	PSI-6206 Impurity M; GS-331007 Impurity; (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine-5'-(phenyl methoxy-L-alaninyl) phosphate impurity M; Sofosbuvir Related Compound M; GS-7977 Impurity M; 5'-O-[(2S)-2-[[(2R)-2-[[(1R)-1-(2,4-Dioxo-3,4-dihydropyrimidin-1(2H)-yl)propan-2-yl]oxy]phenoxy-phosphoryl]amino]propanoate] 2'-Deoxy-2'-fluoro-2'-C-methyluridine
EINECS	Contact for details

Quality Control

Our Sofosbuvir Impurity M is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.