Polidocanol Impurity 2 CAS CATO-C4X-29442

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-29442
Molecular FormulaC31H62O12
Molecular Weight626.82 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Polidocanol Impurity 2 CAS CATO-C4X-29442 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 626.82 g/mol gives Polidocanol Impurity 2 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Polidocanol Impurity 2 (CAS CATO-C4X-29442) is a certified pharmaceutical impurity reference standard with the molecular formula C31H62O12 and a molecular weight of 626.82 g/mol.

Structurally, Polidocanol Impurity 2 (C31H62O12) contains a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 1.0, corresponding to approximately 1 ring(s) or double-bond equivalent(s). With a molecular weight of 626.82 g/mol, it falls into the high-molecular-weight range.

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 FormulaC31H62O12
Molecular Weight626.82 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)1.0

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