Description

Capecitabine Related Substance USP is a high-purity reference standard and impurity used in the pharmaceutical development and quality control of the active pharmaceutical ingredient Capecitabine. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product through precise analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the synthesis, validation, and batch release of oncology medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Capecitabine API and finished dosage forms according to pharmacopeial methods (USP, EP).
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure API and drug product batches meet stringent purity specifications.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to monitor impurity formation pathways in Capecitabine formulations.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Used in research to understand and optimize the synthetic pathway of Capecitabine, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	Capecitabine Related Substance USP
CAS No.	1262133-68-5
Molecular Formula	C15H22FN3O6
Molecular Weight	359.35 g/mol
Synonyms	5'-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine; Capecitabine Impurity; Capecitabine Related Compound; 1-(5-Deoxy-β-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarboxylic acid pentyl ester; 5-Fluoro-1-[5-O-[(pentyloxy)carbonyl]-β-D-ribofuranosyl]-2(1H)-pyrimidinone-4-carboxylic acid; UNII-8V8T8Q178K; Capecitabine EP Impurity G; Capecitabine USP Related Substance
EINECS	Contact for details

Quality Control

This USP-grade reference material is manufactured and tested under strict quality systems. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data for identity, purity, and impurity content, ensuring full traceability and compliance with current pharmacopeial standards. Our quality assurance protocols are designed to meet the rigorous demands of GMP environments for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with USP <467>
Water Content (KF)	≤ 1.0%

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