Description

Sofosbuvir Impurity 8 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Sofosbuvir. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for antiviral drug formulations.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Sofosbuvir API batches.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Used in stability indicating studies to monitor degradation pathways and establish shelf-life for finished drug products.
• Critical component for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Supports pharmaceutical research into the metabolism and degradation chemistry of Sofosbuvir.
• Employed as a system suitability component in pharmacopeial testing to ensure analytical instrument performance.

Basic Information

Product Name	Sofosbuvir Impurity 8
CAS No.	944476-44-2
Molecular Formula	C₂₂H₂₉FN₃O₉P
Molecular Weight	529.46 g/mol
Synonyms	PSI-7977 Impurity 8; GS-7977 Impurity 8; (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine-5'-[Phenyl-(S)-alaninyl]phosphate Impurity; Sofosbuvir Related Compound 8; 5'-O-[(S)-Phenylalanyl]-2'-deoxy-2'-fluoro-2'-C-methyluridine; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Sofosbuvir Impurity 8 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical characterization using techniques including HPLC, LC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results for purity, impurities, and other critical parameters. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

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