Fluorometholone Impurity 8 CAS CATO-C4X-19338

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-19338
Molecular FormulaC22H29FO5
Molecular Weight392.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluorometholone Impurity 8 CAS CATO-C4X-19338 chemical structure

Description

As a certified reference material (CRM), Fluorometholone Impurity 8 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.

CATO supplies Fluorometholone Impurity 8 (CAS CATO-C4X-19338), a pharmacopoeial impurity reference standard (molecular formula C22H29FO5, MW 392.46 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Fluorometholone Impurity 8 (C22H29FO5) is characterized by a flavonoid core, a hydroxyl group, an ether linkage, fluorine substitution. 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.

Physical & Chemical Properties

Molecular FormulaC22H29FO5
Molecular Weight392.46 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing

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