Idebenone Impurity 12 CAS CATO-C4X-301612

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-301612
Molecular FormulaC19H30O6
Molecular Weight354.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Idebenone Impurity 12 CAS CATO-C4X-301612 chemical structure

Description

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.

CATO supplies Idebenone Impurity 12 (CAS CATO-C4X-301612), a pharmacopoeial impurity reference standard (molecular formula C19H30O6, MW 354.44 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Idebenone Impurity 12 (C19H30O6) is characterized by a steroid 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.

Physical & Chemical Properties

Molecular FormulaC19H30O6
Molecular Weight354.44 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at room temperature, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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