Hydrocortisone EP Impurity M CAS 566-35-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.566-35-8
Molecular FormulaC21H30O5
Molecular Weight362.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Hydrocortisone EP Impurity M CAS 566-35-8 chemical structure

Description

The occurrence of Hydrocortisone EP Impurity M is closely related to a flavonoid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Hydrocortisone EP Impurity M (CAS 566-35-8) is a certified pharmaceutical impurity reference standard with the molecular formula C21H30O5 and a molecular weight of 362.46 g/mol.

Hydrocortisone EP Impurity M (C21H30O5) contains a flavonoid core, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 FormulaC21H30O5
Molecular Weight362.46 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
CAS Registry Year (est.)1957

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