Description

Sofosbuvir Impurity 19 is a high-purity reference standard used in the pharmaceutical development and quality control of the antiviral drug Sofosbuvir. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Quality Control & Assurance: Used in HPLC, LC-MS, and other chromatographic systems for the identification and quantification of impurities in Sofosbuvir Active Pharmaceutical Ingredient (API) batches.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity profiles.
• Stability Studies: Employed to monitor impurity levels in Sofosbuvir drug products under various storage conditions over time.
• Process Chemistry Research: Aids in understanding and optimizing the Sofosbuvir synthesis pathway to minimize the formation of this specific impurity.
• Pharmacopoeial Testing: Can be utilized to verify compendial methods as specified in pharmacopoeias like USP or EP.

Basic Information

Product Name	Sofosbuvir Impurity 19
CAS No.	2164516-85-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sofosbuvir Related Compound 19; PSI-7977 Impurity 19; GS-7977 Impurity 19; (2'R)-2'-Deoxy-2'-α-fluoro-2'-β-C-methyluridine Impurity; 5'-O-[(2S)-2-Methylbutanoyl]-3'-O-[(2S)-2-methylbutanoyl] Sofosbuvir Impurity; Sofosbuvir EP Impurity G; Sofosbuvir USP Related Compound
EINECS	Contact for details

Quality Control

Every batch of Sofosbuvir Impurity 19 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques like HPLC and LC-MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Specific Rotation	Contact for details

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