Description

Sofosbuvir Impurity CAS NO 1233335-82-4 is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sofosbuvir. This compound is essential for pharmaceutical manufacturers and research laboratories to identify, quantify, and monitor process-related impurities, ensuring final drug product safety and regulatory compliance. It is primarily used in the development, validation, and routine testing of antiviral medications within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Sofosbuvir API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Sofosbuvir products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Process Chemistry Research: Aids in understanding and optimizing the Sofosbuvir synthesis pathway by tracking the formation and fate of this specific impurity.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to monitor impurity levels over time and under various stress conditions.

Basic Information

Product Name	Sofosbuvir Impurity
CAS No.	1233335-82-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sofosbuvir Related Compound, Sofosbuvir Process Impurity, Sofosbuvir Degradant, Sovaldi Impurity, PSI-7977 Impurity, GS-7977 Impurity, (2'R)-2'-Deoxy-2'-fluoro-2'-methyluridine Impurity, Nucleotide Analog Impurity
EINECS	Contact for details

Quality Control

Every batch of Sofosbuvir Impurity (CAS 1233335-82-4) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, and NMR 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 at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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