Description

Fludarabine Phosphate Ep Impurity C is a critical reference standard and impurity used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Fludarabine Phosphate. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the qualitative and quantitative analysis of Fludarabine Phosphate.
• Impurity Profiling & Control: Used in HPLC and LC-MS methods to identify, monitor, and control the level of this specific impurity in API batches to meet ICH guidelines.
• Method Development & Validation: Critical for developing and validating analytical methods as per regulatory requirements for new drug applications (NDA/ANDA).
• Stability Studies: Employed to track the formation of degradation products in Fludarabine Phosphate under various stress conditions.
• Quality Assurance/Quality Control (QA/QC): An indispensable tool for in-house quality control laboratories to ensure batch-to-batch consistency and compliance.
• Regulatory Compliance & Documentation: Supports regulatory filings and audits by providing necessary data to demonstrate control over the manufacturing process.

Basic Information

Product Name	Fludarabine Phosphate Ep Impurity C
CAS No.	548774-53-4
Molecular Formula	C10H12FN5O7P
Molecular Weight	363.21 g/mol
Synonyms	Fludarabine Impurity C; Fludarabine Phosphate Related Compound C; 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)-; 2-Fluoro-ara-AMP Impurity C; 2-F-ara-AMP Impurity C; Fludarabine Phosphate EP Impurity C; Fludarabine Phosphate Process Impurity; 2-Fluoroadenine Arabinoside 5'-Monophosphate Impurity
EINECS	Contact for details

Quality Control

Every batch of Fludarabine Phosphate Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.