Description

Sofosbuvir Impurity 54 is a designated process-related impurity and reference standard used in the analytical profiling of the antiviral active pharmaceutical ingredient (API) Sofosbuvir. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of potential impurities during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Sofosbuvir.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in QC laboratories to monitor and control the level of this specific impurity in Sofosbuvir API batches to meet ICH Q3A/B thresholds.
• Regulatory Submission & Compliance: Supports the preparation of regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity profiles over time.
• Process Chemistry Research: Aids in understanding and optimizing the Sofosbuvir synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Sofosbuvir Impurity 54
CAS No.	1431932-81-8
Molecular Formula	C22H29FN3O9P
Molecular Weight	529.46 g/mol
Synonyms	PSI-6206 Impurity; GS-331007 Impurity; Sofosbuvir Related Compound 54; (2'R)-2'-Deoxy-2'-fluoro-2'-methyluridine-5'-(phenyl methoxy-L-alaninyl) phosphate impurity; 1-[[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy-oxido-phosphoryl]oxyethyl (2S)-2-amino-2-phenylacetate
EINECS	Contact for details

Quality Control

Every batch of Sofosbuvir Impurity 54 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques like HPLC, LC-MS, and NMR to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use under GMP conditions for pharmaceutical 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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.