Description

Fludarabine Ep Impurity G is a critical pharmaceutical reference standard used in the quality control of the active pharmaceutical ingredient (API) Fludarabine. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a known impurity for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, development, and quality assurance of oncology medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Fludarabine API batches.
• Analytical Method Development: Crucial for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Fludarabine API meets stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of degradation products in Fludarabine drug substance and drug product under various storage conditions.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and impurity formation mechanisms of Fludarabine.

Basic Information

Product Name	Fludarabine Ep Impurity G
CAS No.	548774-56-7
Molecular Formula	C10H12FN5O4
Molecular Weight	285.23 g/mol
Synonyms	2-Fluoroadenine-9-β-D-arabinofuranoside Impurity G; 9-β-D-Arabinofuranosyl-2-fluoroadenine Related Compound G; Fludarabine Related Compound G; 2-Fluoro-ara-A Impurity G; 2-F-ara-A Impurity G; 2-Fluoroadenine Arabinoside Impurity G; Fludarabine EP Impurity G
EINECS	Contact for details

Quality Control

Every batch of Fludarabine Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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