Description

Capecitabine CAS NO 158798-73-3 is an orally administered chemotherapeutic prodrug of 5-fluorouracil (5-FU), specifically designed for targeted activation within tumor tissues. This compound matters for its role in providing a more convenient and potentially less toxic treatment option for patients, particularly in the management of metastatic colorectal and breast cancers. Pharmaceutical manufacturers, research institutions, and compounding facilities require high-purity capecitabine for the production of finished dosage forms and for ongoing clinical research.

Application

• Oncological Pharmaceutical Manufacturing: Primary active pharmaceutical ingredient (API) in the production of oral chemotherapy tablets for colorectal, breast, and gastric cancers.
• Clinical Research & Drug Development: Serves as a key reference standard and raw material in preclinical studies and clinical trials for new cancer treatment regimens and combination therapies.
• Pharmaceutical Compounding: Used in specialized pharmacy settings for preparing patient-specific doses where commercial formulations are unsuitable.
• Biosimilar & Generic Drug Production: Essential raw material for manufacturers developing generic versions of branded capecitabine products.
• Academic & Institutional Research: Utilized in university and hospital laboratories to study mechanisms of action, drug resistance, and novel delivery systems for fluoropyrimidine agents.

Basic Information

Product Name	Capecitabine
CAS No.	158798-73-3
Molecular Formula	C15H22FN3O6
Molecular Weight	359.35 g/mol
Synonyms	5'-Deoxy-5-fluoro-N4[(pentyloxy)carbonyl]cytidine; Xeloda (Brand Name); Ro 09-1978/000; Capecitabin; N4-Pentyloxycarbonyl-5'-deoxy-5-fluorocytidine; 5'-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine
EINECS	Contact for details

Quality Control

Our Capecitabine is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing parameters such as assay, related substances, residual solvents, and identification. We can supply material compliant with various pharmacopoeial standards, including USP and EP monographs, upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches 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.