Description

Sofosbuvir Impurity 21 is a high-purity reference standard used in the analytical profiling 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 an essential material for research and development, method validation, and stability studies within the antiviral drug sector.

Application

• Primary use as a certified reference standard for the identification and quantification of Sofosbuvir-related impurities.
• Critical component in analytical method development and validation (HPLC, LC-MS) for pharmaceutical quality control.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Essential for regulatory compliance and filing (e.g., FDA, EMA) of Sofosbuvir drug substances and products.
• Supports research and development of Sofosbuvir synthesis processes and purification strategies.
• Employed in pharmacopoeial testing to meet standards set by USP, EP, or other international bodies.

Basic Information

Product Name	Sofosbuvir Impurity 21
CAS No.	1496552-50-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sofosbuvir Related Compound 21; PSI-7977 Impurity 21; GS-7977 Impurity 21; (2'R)-2'-Deoxy-2'-fluoro-2'-methyluridine impurity; 2'-Fluoro-2'-methyluridine derivative impurity; Sofosbuvir Process Impurity; Hepatitis C Virus NS5B polymerase inhibitor impurity
EINECS	Contact for details

Quality Control

Every batch of Sofosbuvir Impurity 21 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and 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). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 5.0%

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