Docusate Sodium Impurity 5 CAS 115960-17-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.115960-17-3
Molecular FormulaC12H21NaO7S
Molecular Weight332.35 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Docusate Sodium Impurity 5 CAS 115960-17-3 chemical structure

Description

Docusate Sodium Impurity 5 (C12H21NaO7S) contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions.

As a process- or degradation-related impurity, Docusate Sodium Impurity 5 (CAS 115960-17-3, C12H21NaO7S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical 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 FormulaC12H21NaO7S
Molecular Weight332.35 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.5
CAS Registry Year (est.)1990
Sulfur Atoms1

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