Description

Fludarabine Phosphate Impurity F is a critical reference standard 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 analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the production and validation of oncology medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for analytical method development and validation in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Used for the precise identification and quantification of Fludarabine Phosphate Impurity F in API and finished drug product batches to ensure compliance with strict pharmacopeial specifications.
• Stability Studies: Employed as a marker to monitor impurity profiles and degradation pathways of Fludarabine Phosphate under various storage conditions.
• Process Chemistry R&D: Aids in the optimization of synthesis and purification processes by tracking the formation and removal of this specific impurity.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate product quality and control strategy.
• Contract Research Organizations (CROs): Utilized by third-party testing facilities to provide analytical services for pharmaceutical clients.

Basic Information

Product Name	Fludarabine Phosphate Impurity F
CAS No.	159002-28-5
Molecular Formula	C10H12FN5O4
Molecular Weight	285.23 g/mol
Synonyms	2-Fluoroadenine-9-β-D-arabinofuranoside 5'-Monophosphate Impurity F; 9-β-D-Arabinofuranosyl-2-fluoroadenine 5'-Monophosphate Related Compound F; 2-Fluoro-ara-AMP Impurity F; 2-F-ara-AMP Impurity F; Fludarabine 5'-Monophosphate Impurity F; Fludarabine Phosphate Related Substance F; NSC 118218 Impurity F
EINECS	Contact for details

Quality Control

Every batch of Fludarabine Phosphate Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material under an inert atmosphere if necessary to prevent degradation.

Specification

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

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