Polidocanol Impurity 4 (Polidocanol E14) CAS 54350-53-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.54350-53-7
Molecular FormulaC40H82O15
Molecular Weight803.07 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Polidocanol Impurity 4 (Polidocanol E14) CAS 54350-53-7 chemical structure

Description

The occurrence of Polidocanol Impurity 4 (Polidocanol E14) is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Polidocanol Impurity 4 (Polidocanol E14) (CAS 54350-53-7), a pharmacopoeial impurity reference standard (molecular formula C40H82O15, MW 803.07 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C40H82O15, Polidocanol Impurity 4 (Polidocanol E14) contains a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 803.07 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry.

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 FormulaC40H82O15
Molecular Weight803.07 g/mol
Purity>95%
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
CAS Registry Year (est.)1972

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