Description

Sofosbuvir Impurity 32 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Sofosbuvir, a key antiviral medication. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling. The reliable identification and quantification of this impurity are fundamental to maintaining the highest standards in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Sofosbuvir API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies & Forced Degradation: Used to monitor and characterize degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Pharmaceutical Research (R&D): Serves as a key intermediate or impurity marker in synthetic pathway research and process chemistry optimization for Sofosbuvir.
• Quality Control (QC) Testing: Used as a system suitability standard and for routine batch release testing to ensure impurity levels are within specified limits.

Basic Information

Product Name	Sofosbuvir Impurity 32
CAS No.	1157884-58-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sofosbuvir Related Compound 32; PSI-7977 Impurity 32; GS-7977 Impurity 32; (2'R)-2'-Deoxy-2'-fluoro-2'-methyluridine Phosphoramidate Prodrug Impurity; Sofosbuvir Process Impurity; Sofosbuvir Degradant; Sovaldi® Impurity 32
EINECS	Contact for details

Quality Control

Our Sofosbuvir Impurity 32 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods (NMR, MS) for structural verification, to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to ensure long-term stability. For extended storage, consider storing under an inert atmosphere such as argon or nitrogen.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0% (Area Percent)
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.