Capecitabine

Synonyms: Capecitabine, 154361-50-9, Xeloda, Ro 09-1978, 5′-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine

Capecitabine has become a cornerstone in oral chemotherapy regimens, drawing consistent demand from generic drug manufacturers and research organizations worldwide. Its ability to be administered orally, unlike many traditional chemotherapeutics, has made it a preferred choice for both clinical use and formulation development. As patents expire and healthcare systems seek cost-effective alternatives, the need for high-quality API from reliable suppliers continues to grow.

Chemically, capecitabine is a fluoropyrimidine carbamate prodrug of 5-fluorouracil (5-FU). It is synthesized through a multi-step process that introduces a pentyloxycarbonyl group to the cytidine ring, enhancing oral bioavailability. The compound is manufactured under strict conditions to ensure consistent purity and performance, with final crystallization yielding a white to off-white powder that meets pharmacopeial standards.

Our capecitabine is produced under GMP conditions and standardized to 98.0% – 102.0% assay by HPLC. It is available in bulk quantities, supported by comprehensive documentation and fast turnaround, making it suitable for generic formulation, clinical research, and reference standard applications.

Product Overview & Composition

Capecitabine is a synthetic nucleoside analog that acts as a prodrug. After oral administration, it undergoes enzymatic conversion to 5-FU, which inhibits thymidylate synthase and disrupts DNA synthesis. This targeted activation within tumor tissues reduces systemic toxicity compared to intravenous 5-FU.

The API is characterized by its high purity and consistent particle size distribution, critical for reproducible tablet manufacturing. Each batch is tested for identity, assay, and impurity profile to ensure compliance with USP/EP monographs.

Applications & Product Lines

• Generic Oncology Drugs: Used in the production of capecitabine tablets for colorectal and breast cancer treatment.
• Clinical Research: Serves as an active comparator or reference standard in oncology studies.
• Formulation Development: Employed in the development of improved oral dosage forms with enhanced bioavailability.
• Contract Manufacturing: Supplied to CDMOs for the production of finished dosage forms.
• Reference Standards: Available as a secondary reference standard for analytical method validation.

Quality Control Standards

Bulk Packaging & Supply

• Packaging: 25 kg fiber drums with double polyethylene bags inside.
• MOQ: 1 kg
• Lead time: 3-5 business days (stock items)
• Documentation: COA, MSDS, TDS available upon request.

Frequently Asked Questions

What is the minimum order quantity (MOQ) for capecitabine?

Our MOQ is 1 kg. For larger quantities, we offer competitive pricing and flexible shipping terms.

What is the delivery time?

For stock items, delivery time is 3-5 business days after order confirmation.

Can you provide a COA and samples?

Yes, we provide a COA for each batch and can supply samples for quality evaluation. Please contact us for details.

Contact & Ordering Information

• Company: LyvBio Co., Ltd.
• Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
• Email: info@lyvbio.com
• Phone: +86-29-65816888

send us your specification for a quotation.