Description

Fludarabine Phosphate 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, specifically designed to disrupt DNA synthesis in rapidly dividing cells. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for hematologic malignancies. The product is supplied as a high-purity material, meeting the stringent requirements for pharmaceutical synthesis and advanced clinical research.

Application

• Pharmaceutical API Synthesis: Primary use as the active ingredient in injectable formulations for chemotherapy.
• Oncology Drug Manufacturing: Core component in the production of drugs for treating chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma, and acute myeloid leukemia (AML).
• Clinical Research & Development: Used in preclinical and clinical studies to develop new anticancer therapies and combination regimens.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.
• Biochemical Research: Utilized in studies investigating nucleoside metabolism, DNA repair mechanisms, and apoptosis induction.

Basic Information

Product Name	Fludarabine Phosphate
CAS No.	75607-67-9
Molecular Formula	C10H13FN5O7P
Molecular Weight	365.21 g/mol
Synonyms	Fludarabine 5'-Monophosphate; 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)-; 2-Fluoro-ara-AMP; 2-F-ara-AMP; Fludara (brand name); NSC 312887; (2R,3S,4S,5R)-2-(6-Amino-2-fluoro-9H-purin-9-yl)-5-(hydroxymethyl)oxolane-3,4-diol dihydrogen phosphate; β-2-Fluoro-arabinofuranosyladenine 5'-monophosphate
EINECS	Contact for details

Quality Control

Our Fludarabine Phosphate is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and stringent control of related substances, to ensure it meets high-grade pharmaceutical specifications. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability, consistency, and compliance with relevant guidelines.

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)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 10 EU/mg
Microbial Enumeration	Meets Ph. Eur. / USP criteria for non-sterile substances

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