Description

Fludarabine Phosphate EP Impurity A is a critical reference standard used in the pharmaceutical quality control process. This compound is essential for ensuring the purity and safety of the active pharmaceutical ingredient, Fludarabine Phosphate, a key medication in chemotherapy regimens. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and batch release testing. Utilizing this high-purity impurity standard is fundamental for compliance with stringent pharmacopoeial monographs from the European Pharmacopoeia (EP) and other global regulatory standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for qualitative and quantitative analysis in HPLC and LC-MS methods.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical procedures to detect and quantify this specific impurity.
• Quality Control and Batch Release: Used in the routine testing of Fludarabine Phosphate API and finished drug products to ensure they meet EP, USP, or ICH impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products in Fludarabine Phosphate formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and improve manufacturing processes.

Basic Information

Product Name	Fludarabine Phosphate EP Impurity A
CAS No.	62314-92-5
Molecular Formula	C10H12FN5O4
Molecular Weight	285.23 g/mol
Synonyms	2-Fluoroadenine-9-β-D-arabinofuranoside 5'-Monophosphate; 9-β-D-Arabinofuranosyl-2-fluoroadenine 5'-Monophosphate; 2-Fluoro-ara-AMP; 2-F-ara-AMP; Fludarabine 5'-Monophosphate Related Compound A; Fludarabine Phosphate Impurity A; 2-Fluoroadenine Arabinoside Monophosphate
EINECS	Contact for details

Quality Control

Every batch of Fludarabine Phosphate EP Impurity A is manufactured and analyzed under strict quality management systems. The product is characterized and qualified against pharmacopoeial standards using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurity profile. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.