Description

Fludarabine Phosphate Impurity B is a specified impurity of the active pharmaceutical ingredient Fludarabine Phosphate, a key chemotherapeutic agent. This impurity is critical for pharmaceutical manufacturers to monitor and control to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is an essential reference standard for analytical method development, validation, and quality control in the production of Fludarabine Phosphate and its formulations.

Application

• Primary use as a pharmaceutical reference standard for analytical testing.
• Critical component in impurity profiling and method validation for Fludarabine Phosphate API.
• Used in stability studies to track impurity formation under various storage conditions.
• Essential for quality control (QC) and quality assurance (QA) laboratories in pharmaceutical manufacturing.
• Supports research and development (R&D) of generic formulations of Fludarabine Phosphate.
• Required for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategy.

Basic Information

Product Name	Fludarabine Phosphate Impurity B
CAS No.	149297-79-0
Molecular Formula	C10H12FN5O4
Molecular Weight	285.23 g/mol
Synonyms	2-Fluoro-9H-purin-6-amine, 9-β-D-arabinofuranosyl-; 9-β-D-Arabinofuranosyl-2-fluoro-9H-purin-6-amine; 2-Fluoro-ara-adenine; 2-F-ara-A; Fludarabine related compound B; Fludarabine Impurity B; 2-Fluoroadenine arabinoside impurity B
EINECS	Contact for details

Quality Control

Every batch of Fludarabine Phosphate Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment.

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 compound is hygroscopic (moisture-sensitive) and should be kept under inert conditions or in a desiccator to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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