Description

Capecitabinealfa Alfa Impurity2 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Capecitabine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Capecitabine-based formulations.

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.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products in Capecitabine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the API.

Basic Information

Product Name	Capecitabinealfa Alfa Impurity2
CAS No.	1810778-34-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Capecitabine Impurity 2; Capecitabine Related Compound 2; Capecitabinealfa Alfa Impurity 2; Capecitabine EP Impurity B; Capecitabine USP Impurity; 5'-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine Impurity; 5'-DFCR Impurity; N4-Pentyloxycarbonyl-5'-deoxy-5-fluorocytidine Impurity
EINECS	Contact for details

Quality Control

Our Capecitabinealfa Alfa Impurity2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results, storage recommendations, and retest dates.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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