Idebenone Impurity 2 CAS CATO-C4X-30162

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-30162
Molecular FormulaC38H60O8
Molecular Weight644.88 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Idebenone Impurity 2 CAS CATO-C4X-30162 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 Idebenone Impurity 2.

CATO supplies Idebenone Impurity 2 (CAS CATO-C4X-30162), a pharmacopoeial impurity reference standard (molecular formula C38H60O8, MW 644.88 g/mol) used for the identification and quantification of trace impurities in APIs.

Idebenone Impurity 2 (C38H60O8) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC38H60O8
Molecular Weight644.88 g/mol
Purity97%+
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
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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