Description

Sofosbuvir Impurity 19 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Sofosbuvir. This compound is critical for ensuring the purity, safety, and efficacy of antiviral drug formulations by serving as a benchmark for impurity identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory bodies involved in the development and manufacture of Hepatitis C therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in Sofosbuvir analysis.
• Method Development and Validation: Crucial for developing, validating, and transferring analytical methods in compliance with ICH Q2(R1) guidelines.
• Quality Control and Batch Release: Used in the routine testing of Sofosbuvir API batches to monitor and control impurity levels, ensuring they meet pharmacopeial (USP, EP) and internal specifications.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the Sofosbuvir synthesis pathway by identifying process-related impurities.

Basic Information

Product Name	Sofosbuvir Impurity 19
CAS No.	1064684-71-4
Molecular Formula	C₂₂H₂₉FN₃O₉P
Molecular Weight	529.46 g/mol
Synonyms	PSI-7977 Impurity 19; GS-7977 Impurity 19; (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine-5'-(phenyl methoxy-L-alaninyl) phosphate impurity 19; Sofosbuvir Related Compound 19; Sovaldi Impurity 19; 5'-O-[(2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridin-5'-yl]-(phenyl methoxy-L-alaninyl) phosphate impurity
EINECS	Contact for details

Quality Control

Our Sofosbuvir Impurity 19 is manufactured under strict quality systems and undergoes rigorous analytical characterization to ensure identity, purity, and suitability as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. We support compliance with ICH Q3A, Q3B, and Q6A guidelines, and our quality commitment aligns with cGMP standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term stability, storage at -20°C is recommended. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.