Description

Capecitabin Impurity CAS NO 71609-08-0 is a high-purity reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Capecitabine. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and routine quality control testing to monitor and control impurities in the final drug product.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Capecitabine API and finished dosage forms.
• Analytical Method Development: Used in research and quality control (QC) laboratories to develop and validate sensitive analytical methods, primarily High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity profiles and justify specification limits as per ICH Q3A and Q3B guidelines.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways during forced degradation and long-term stability studies of Capecitabine.
• Process Chemistry Research: Used by process development scientists to understand and optimize synthesis pathways, aiming to minimize the formation of this impurity.
• Quality Assurance/Quality Control (QA/QC): A critical component for in-house quality control testing to ensure batch-to-batch consistency and compliance with established pharmacopeial or in-house specifications.

Basic Information

Product Name	Capecitabin Impurity
CAS No.	71609-08-0
Molecular Formula	C15H22FN3O6
Molecular Weight	359.35 g/mol
Synonyms	5'-Deoxy-5-fluoro-N4-(pentyloxycarbonyl)cytidine; 5'-Deoxy-5-fluoro-N4-(pentyloxycarbonyl)cytidine; Capecitabine Impurity; Capecitabine Related Compound; 1-(5-Deoxy-β-D-ribofuranosyl)-5-fluoro-4-(pentyloxycarbonylamino)-2(1H)-pyrimidinone; 4-Amino-1-(5-deoxy-β-D-ribofuranosyl)-5-fluoro-2(1H)-pyrimidinone, 4-(pentyloxycarbonyl)-; UNII-6W5Q4F6O8P
EINECS	Contact for details

Quality Control

Our Capecitabin Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. Certificates of Analysis (COA) detailing all test results against stringent specifications are provided to ensure compliance with pharmacopeial standards and support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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