Description

Sofosbuvir Impurity CAS NO 1520010-86-9 is a high-purity reference standard used for analytical and research purposes in the pharmaceutical industry. This compound is critical for ensuring the quality, safety, and efficacy of the antiviral drug Sofosbuvir by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and quality control processes.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Sofosbuvir active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity levels remain within specified regulatory limits.
• Stability Studies: Used to track the formation and level of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., to FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Research and Development: Facilitates studies on impurity formation pathways, degradation chemistry, and process optimization during Sofosbuvir synthesis.

Basic Information

Item	Details
Product Name	Sofosbuvir Impurity
CAS No.	1520010-86-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sofosbuvir Related Compound; Sofosbuvir Impurity Standard; Sofosbuvir Process Impurity; (2'R)-2'-Deoxy-2'-α-fluoro-2'-β-C-methyluridine-5'-(phenyl methoxy-L-alaninyl) phosphate impurity; PSI-7977 Impurity; GS-7977 Impurity; Sovaldi Impurity
EINECS	Contact for details

Quality Control

Every batch of our Sofosbuvir Impurity is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and strength. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards are designed to support compliance with ICH Q3A, Q3B, and Q6A guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to 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

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