Description

Fludarabine is a synthetic purine nucleoside analog and a critical active pharmaceutical ingredient (API) with potent antineoplastic properties. Its primary value lies in its role as a key chemotherapeutic agent, interfering with DNA synthesis and inducing apoptosis in rapidly dividing cells. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for hematological malignancies, particularly chronic lymphocytic leukemia (CLL).

Application

• Oncological Pharmaceutical Manufacturing: Primary use as the active pharmaceutical ingredient (API) in injectable formulations for chemotherapy.
• Treatment of Hematologic Cancers: Specifically indicated for the treatment of B-cell chronic lymphocytic leukemia (CLL) in patients who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent-containing regimen.
• Conditioning Regimens in Hematopoietic Stem Cell Transplantation (HSCT): Used in reduced-intensity conditioning regimens prior to allogeneic stem cell transplantation.
• Research & Development: Serves as a reference standard and a key intermediate in biochemical research focused on nucleoside metabolism, apoptosis, and the development of novel anticancer therapies.
• Formulation Development: Used in the development of novel drug delivery systems, including liposomal and targeted formulations to improve therapeutic efficacy and reduce side effects.

Basic Information

Product Name	Fludarabine
CAS No.	21679-14-1
Molecular Formula	C10H12FN5O4
Molecular Weight	285.23 g/mol
Synonyms	Fludarabine; 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)-; 2-Fluoro-ara-AMP; 2-F-ara-AMP; NSC 118218; Fludara (brand name); 2-Fluoroadenine arabinoside 5'-monophosphate; β-2-Fluoro-arabinofuranosyladenine 5'-monophosphate
EINECS	Contact for details

Quality Control

Our Fludarabine is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided with every shipment to guarantee traceability and compliance.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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