Fluticasone Impurity 21 CAS 397864-40-3

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.397864-40-3
Molecular FormulaC26H28F2O6S
Molecular Weight506.56 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluticasone Impurity 21 CAS 397864-40-3 chemical structure

Description

The occurrence of Fluticasone Impurity 21 is closely related to a steroid core, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Fluticasone Impurity 21 (CAS 397864-40-3) is a certified pharmaceutical impurity reference standard with the molecular formula C26H28F2O6S and a molecular weight of 506.56 g/mol.

Structurally, Fluticasone Impurity 21 (C26H28F2O6S) contains a steroid core, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 506.56 g/mol, it falls into the moderately-high-molecular-weight range. 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), Fluticasone Impurity 21 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 FormulaC26H28F2O6S
Molecular Weight506.56 g/mol
Purity>90%
StorageStore at room temperature, 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentF-containing
Sulfur Atoms1

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