Fluticasone Propionate EP Impurity H CAS 201812-64-8

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Fluticasone Propionate EP Impurity H.

CATO supplies Fluticasone Propionate EP Impurity H (CAS 201812-64-8), a pharmacopoeial impurity reference standard (molecular formula C48H58F4O10S2, MW 935.09 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Fluticasone Propionate EP Impurity H (C48H58F4O10S2) is characterized by a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional 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.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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