Category
Fludarabine
CAS Number
Fludarabine STD-21679-14-1;75607-67-9(Phosphate salt): IMP-D-700-49-2: IMP-E-21679-14-1: IMP-F-159002-28-5
Molecular Formula
Fludarabine STD-C10H12FN5O4: IMP-D-C5H4FN5: IMP-E-C10H12FN5O4: IMP-F-C12H18N5O8P
Molecular Weight
Fludarabine STD-285.24: IMP-D-153.12: IMP-E-285.23: IMP-F-391.28
Synonym

Fludarabine STD-(2R,3S,4S,5R)-2-(6-amino-2-fluoropurin-9-yl)-5-(hydroxymethyl)oxolane-3,4-diol; 9-β-D-Arabinofuranosyl-2-fluoro-9H-purin-6-amine; 2-Fluoro-9-β-D-arabinofuranosyladenine;2-Fluoroadenine Arabinoside; (2R,3S,4S,5R)-2-(6-amino-2-fluoro-9H-purin-9-yl)-5-(hydroxymethyl)tetrahydrofuran-3,4-diol; Adenine,9-β-D-arabinofuranosyl-2-fluoro; 9-b-D-Arabinofuranosyl-2-fluoroadenine; NSC 118218; NSC 118218H

Fludarabine EP-Impurity-D-2-fluoro-7H-purin-6-amine; 2-Fluoro-9H-purin-6-amine; 2-Fluoro-1H-purin-6-amine; 2-Fluoro-adenine; 2-Fluoro-6-aminopurine; 2-Fluoroadenine (USP); 2-Fluoroadenine

Fludarabine EP-Impurity-E-(2R,3R,4S,5R)-2-(6-amino-2-fluoro-9H-purin-9-yl)-5-(hydroxymethyl)tetrahydrofuran-3,4-diol; (2R,3S,4S,5R)-2-(6-Amino-2-fluoro-9H-purin-9-yl)-5-(hydroxymethyl)tetrahydrofuran-3,4-diol; Fludarabine Phosphate 2-Fluoro-ara-adenine; 9-β-d-Arabinofuranosyl-2-fluoroadenine (USP)

Fludarabine EP-Impurity-F-[(2R,3S,4S,5R)-5-(6-amino-2-ethoxypurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl dihydrogen phosphate; 2-Ethoxy-9-(5-O-phosphono-β-D-arabinofuranosyl)-9H-purin-6-amine

slide.1
Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Fludarabine Chemical Reference Standard (CRS) is used in analytical laboratories to verify system suitability in chromatographic methods such as HPLC. It provides a reference peak for retention time, peak shape, and resolution, ensuring that the analytical system is functioning correctly before sample analysis. This helps guarantee accurate, consistent, and reproducible results in the quality control of fludarabine drug substances and formulations.