Description

Capecitabine-D11 is a deuterated stable isotope-labeled analog of the chemotherapeutic agent capecitabine. This high-purity reference standard is essential for ensuring accurate and reliable results in quantitative analytical methods, particularly in pharmacokinetic and metabolism studies. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in advanced drug development and bioanalytical research.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard for the precise quantification of capecitabine and its metabolites in biological matrices using liquid chromatography-tandem mass spectrometry.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Bioanalytical Method Development and Validation: Used as a reference material to develop, optimize, and validate sensitive and specific analytical methods compliant with GLP and FDA/EMA guidelines.
• Stable Isotope Labeling Studies: Facilitates mechanistic studies of drug pathways and metabolic stability without interfering with the compound's chemical properties.
• Quality Control in Manufacturing: Acts as a reference standard for the quality control and purity assessment of non-labeled capecitabine in active pharmaceutical ingredient (API) production.

Basic Information

Product Name	Capecitabine-D11
CAS No.	1132662-08-8
Molecular Formula	C15H13D11FN3O6
Molecular Weight	378.38 g/mol
Synonyms	5'-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-D11-cytidine; Capecitabine (D11); Capecitabine-d11; 5'-Deoxy-5-fluorocytidine-2',3',4',5,1',2',3',4',5',6',6'-D11 N4-pentyloxycarbonyl; Xeloda-D11; Ro 09-1978/000-D11; N4-Pentyloxycarbonyl-5'-deoxy-5-fluorocytidine-D11
EINECS	Contact for details

Quality Control

Our Capecitabine-D11 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for assay, isotopic enrichment, and impurity profiles. We adhere to relevant industry standards for reference materials to guarantee reproducibility and traceability in your research.

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 COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Isotopic Purity (D-content)	≥98.0 atom % D
Chemical Purity (HPLC)	≥98.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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