Fludarabine Phosphate EP Impurity C CAS 548774-53-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.548774-53-4
Molecular FormulaC10H14FN5O10P2
Molecular Weight445.19 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fludarabine Phosphate EP Impurity C CAS 548774-53-4 chemical structure

Description

CATO manufactures Fludarabine Phosphate EP Impurity C under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

As a process- or degradation-related impurity, Fludarabine Phosphate EP Impurity C (CAS 548774-53-4, C10H14FN5O10P2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Fludarabine Phosphate EP Impurity C (C10H14FN5O10P2) contains a carbohydrate-derived structure, an amide group, a phosphate ester group, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 445.19 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

Physical & Chemical Properties

Molecular FormulaC10H14FN5O10P2
Molecular Weight445.19 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity>95%
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1984
Halogen ContentF-containing
Nitrogen Atoms5

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