Fludarabine Phosphate EP Impurity C Disodium Salt CAS CATO-C4X-184621

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-184621
Molecular FormulaC10H12FN5O10P2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fludarabine Phosphate EP Impurity C Disodium Salt CAS CATO-C4X-184621 chemical structure

Description

CATO supplies Fludarabine Phosphate EP Impurity C Disodium Salt (CAS CATO-C4X-184621), a pharmacopoeial impurity reference standard (molecular formula C10H12FN5O10P2Na, MW 466.17 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Fludarabine Phosphate EP Impurity C Disodium Salt (C10H12FN5O10P2Na) is characterized by a carbohydrate-derived structure, an amide group, a phosphate ester group, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Fludarabine Phosphate EP Impurity C Disodium Salt meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC10H12FN5O10P2 2*Na
Molecular Weight466.17 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms5

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