Polidocanol Impurity 6 CAS CATO-C4X-29446

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-29446
Molecular FormulaC28H58O10
Molecular Weight554.75 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Polidocanol Impurity 6 CAS CATO-C4X-29446 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 Polidocanol Impurity 6.

CATO supplies Polidocanol Impurity 6 (CAS CATO-C4X-29446), a pharmacopoeial impurity reference standard (molecular formula C28H58O10, MW 554.75 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Polidocanol Impurity 6 (C28H58O10) is characterized by a carboxylic acid group, 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.

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 FormulaC28H58O10
Molecular Weight554.75 g/mol
Purity97%+
StorageStore at room temperature, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)0.0

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