Description

Fludarabine Ep Impurity H is a specified impurity of the antineoplastic drug Fludarabine Phosphate, used in pharmaceutical research and development. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories involved in the production and testing of Fludarabine-based chemotherapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Fludarabine Phosphate impurities in drug substances and products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific impurity over time and under various stress conditions.
• Quality Control & Batch Release: Essential for setting specification limits and conducting routine quality control testing of active pharmaceutical ingredients (APIs) to ensure compliance with pharmacopeial standards (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings with agencies such as the FDA and EMA.
• Process Chemistry Research: Used by chemists to understand and optimize the synthesis pathway of Fludarabine Phosphate to minimize the formation of this impurity.

Basic Information

Product Name	Fludarabine Ep Impurity H
CAS No.	548774-57-8
Molecular Formula	C10H12FN5O4
Molecular Weight	285.23 g/mol
Synonyms	9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)-; 2-Fluoro-ara-AMP; 2-Fluoroadenine arabinoside 5'-monophosphate impurity; Fludarabine 5'-monophosphate related compound H; Fludarabine phosphate impurity H; 2-F-ara-AMP; 9-β-D-Arabinofuranosyl-2-fluoroadenine 5'-monophosphate
EINECS	Contact for details

Quality Control

Every batch of Fludarabine Ep Impurity H is manufactured and analyzed under strict quality management systems. It undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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