Description

Capecitabine CAS NO 38838-07-2 is a rationally designed, orally administered prodrug of 5-fluorouracil (5-FU), a cornerstone chemotherapeutic agent. Its primary value lies in its targeted activation within tumor tissues, which can enhance efficacy while potentially reducing systemic side effects compared to traditional 5-FU administration. This compound is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of oncology therapeutics, particularly for treating colorectal, breast, and gastric cancers.

Application

• Active Pharmaceutical Ingredient (API): Primary use as the key active component in formulated anti-cancer medications.
• Oncology Drug Manufacturing: Bulk synthesis for the commercial production of oral chemotherapy drugs such as Xeloda® and its generic equivalents.
• Pharmaceutical Research & Development: Serving as a critical reference standard and starting material in preclinical and clinical studies for new cancer treatment regimens.
• Combination Therapy Development: Used in research to develop and evaluate synergistic effects with other chemotherapeutic agents or targeted therapies.
• Dosage Form Development: Utilized in the formulation of various oral dosage forms, including tablets and capsules, ensuring stability and bioavailability.
• Analytical Standard: Acting as a high-purity standard for quality control testing, method validation, and regulatory submissions in pharmaceutical labs.

Basic Information

Product Name	Capecitabine
CAS No.	38838-07-2
Molecular Formula	C15H22FN3O6
Molecular Weight	359.35 g/mol
Synonyms	5'-Deoxy-5-fluoro-N4[(pentyloxy)carbonyl]cytidine; N4-Pentyloxycarbonyl-5'-deoxy-5-fluorocytidine; Xeloda; Ro 09-1978/000; CAPE; 5-Fluoro-1-[5-deoxy-β-D-ribofuranosyl]-5-oxy-N-[(pentyloxy)carbonyl]cytosine
EINECS	Contact for details

Quality Control

Our Capecitabine is manufactured under strict quality management systems, targeting standards suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via advanced techniques like HPLC. A Certificate of Analysis (COA) is provided with every shipment, detailing the specific results for that lot. We support compliance with major pharmacopoeial guidelines (e.g., USP, EP) and can provide documentation for regulatory submissions.

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 desiccants or inert atmosphere conditions.

Specification

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

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