Description

Sofosbuvir Impurity 53 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sofosbuvir. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference standard for method development, validation, and routine batch testing in the production of antiviral medications.

Application

• Primary use as a certified reference standard for the identification and quantification of Sofosbuvir Impurity 53 in API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Critical for regulatory submissions (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Supports research and development of Sofosbuvir and related pharmaceutical compounds.
• Employed in pharmacopoeial testing to verify compliance with monograph specifications (e.g., USP, EP).

Basic Information

Product Name	Sofosbuvir Impurity 53
CAS No.	1015255-46-5
Molecular Formula	C22H29FN3O9P
Molecular Weight	529.46 g/mol
Synonyms	PSI-6206 Impurity; GS-331007 Impurity; (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine-5'-(phenyl methoxy-L-alaninyl) phosphate impurity; Sofosbuvir Related Compound 53; Sofosbuvir EP Impurity G; GS-7977 Impurity; 5'-O-[(2S)-2-[[(2R)-[[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy]-phenoxy-phosphoryl]amino]propanoate]
EINECS	Contact for details

Quality Control

Every batch of Sofosbuvir Impurity 53 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and precise identification. Certificates of Analysis (COA) are provided, detailing purity, identity, and impurity profiles. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant pharmacopoeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 2.0%
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.