Description

Sofosbuvir Impurity J is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Sofosbuvir, a key medication in antiviral therapy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and production of hepatitis C treatments.

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 in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits.
• Quality Control & Batch Release Testing: Essential for routine impurity profiling to ensure drug substance and product meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor impurity formation and degradation pathways of Sofosbuvir under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to agencies like the FDA and EMA.
• Research & Development: Aids in process chemistry optimization to understand and minimize impurity formation during synthesis.

Basic Information

Item	Details
Product Name	Sofosbuvir Impurity J
CAS No.	1334513-10-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sofosbuvir Related Compound J; PSI-7977 Impurity J; GS-7977 Impurity J; (2'R)-2'-Deoxy-2'-α-fluoro-2'-β-C-methyluridine Impurity J; Phosphoramidate prodrug impurity J; Sofosbuvir Process Impurity J
EINECS	Contact for details

Quality Control

Our Sofosbuvir Impurity J is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH guidelines.

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.