Hydrocortisone EP Impurity H CAS CATO-C4X-14018

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-14018
Molecular FormulaC21H30O6
Molecular Weight378.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Hydrocortisone EP Impurity H CAS CATO-C4X-14018 chemical structure

Description

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

CATO supplies Hydrocortisone EP Impurity H (CAS CATO-C4X-14018), a pharmacopoeial impurity reference standard (molecular formula C21H30O6, MW 378.46 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Hydrocortisone EP Impurity H (C21H30O6) is characterized by a flavonoid core, a hydroxyl group, an ether linkage. 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. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

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

Molecular FormulaC21H30O6
Molecular Weight378.46 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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