Description

Cladribine is a synthetic purine nucleoside analog with potent antineoplastic and immunosuppressive properties. Its primary value lies in its ability to selectively target and deplete lymphocytes, making it a critical active pharmaceutical ingredient (API) for targeted therapeutic applications. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for specific hematological malignancies and autoimmune disorders. Cladribine CAS NO 4291-63-8 is supplied under stringent quality control to ensure consistency and efficacy in final drug formulations.

Application

• Pharmaceutical API: Primary use as the active ingredient in injectable and oral formulations for chemotherapy.
• Oncology Therapeutics: Manufacture of drugs for treating hairy cell leukemia (HCL) and certain types of lymphoma.
• Multiple Sclerosis (MS) Treatment: Key component in oral disease-modifying therapies (DMTs) for relapsing forms of MS.
• Immunosuppressive Research: Used in preclinical and clinical research to study mechanisms of lymphocyte depletion and immune modulation.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in pharmaceutical labs.
• Process Development: Utilized in the R&D and scale-up of synthetic routes for cladribine-based pharmaceuticals.

Basic Information

Product Name	Cladribine
CAS No.	4291-63-8
Molecular Formula	C10H12ClN5O3
Molecular Weight	285.69 g/mol
Synonyms	2-Chloro-2'-deoxyadenosine; 2-CdA; Leustatin; Litak; Movectro; 2-Chlorodeoxyadenosine; (2R,3S,5R)-5-(6-Amino-2-chloro-9H-purin-9-yl)-2-(hydroxymethyl)tetrahydrofuran-3-ol; RWJ-26251
EINECS	224-310-9

Quality Control

Our Cladribine is manufactured and tested to meet the highest pharmacopeial standards, including USP and EP monographs where applicable. Every batch undergoes rigorous analytical testing for identity, purity, potency, and specified impurities using validated methods such as HPLC, NMR, and mass spectrometry. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment to ensure full traceability and compliance with cGMP guidelines for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified on the label. 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%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Specific Rotation	-20° to -24° (c=1 in DMSO)
Microbial Enumeration	Meets USP <61> requirements

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