Description

Capecitabine CAS NO 154361-50-9 is an orally administered chemotherapeutic prodrug of 5-fluorouracil (5-FU), designed for targeted activation within tumor tissues. This compound is a critical active pharmaceutical ingredient (API) valued for its role in the treatment of specific cancers, offering a more convenient and potentially targeted therapeutic option. It is primarily required by pharmaceutical manufacturers and research institutions engaged in oncology drug development and production.

Application

• Primary use as the Active Pharmaceutical Ingredient (API) in the formulation of oral anti-cancer medications.
• Manufacturing of finished dosage forms, such as tablets, for the treatment of metastatic breast cancer and colorectal cancer.
• Key component in oncology research and development for studying prodrug activation mechanisms and combination therapies.
• Reference standard in analytical laboratories for quality control and method validation (HPLC, LC-MS).
• Used in preclinical and clinical studies to evaluate new treatment regimens and efficacy.
• Starting material for the synthesis of related fluoropyrimidine derivatives in pharmaceutical chemistry.

Basic Information

Product Name	Capecitabine
CAS No.	154361-50-9
Molecular Formula	C15H22FN3O6
Molecular Weight	359.35 g/mol
Synonyms	5'-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine; Xeloda (Trade Name); Ro 09-1978; Capecitabin; N4-Pentyloxycarbonyl-5'-deoxy-5-fluorocytidine; 5-Fluoro-1-(5-deoxy-β-D-ribofuranosyl)-N4-(pentyloxycarbonyl)cytosine; 1-(5-Deoxy-β-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-N4-[(pentyloxy)carbonyl]-4-pyrimidinamine
EINECS	Contact for details

Quality Control

Our Capecitabine is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Each batch undergoes rigorous analytical testing, including HPLC assay for purity and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. We support compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the original container is kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm

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