Simethicone Impurity N3 CAS 3081-07-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3081-07-0
Molecular FormulaC8H26O5Si4
Molecular Weight314.63 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Simethicone Impurity N3 CAS 3081-07-0 chemical structure

Description

The occurrence of Simethicone Impurity N3 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.

As a process- or degradation-related impurity, Simethicone Impurity N3 (CAS 3081-07-0, C8H26O5Si4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Simethicone Impurity N3 (C8H26O5Si4) contains 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.

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 FormulaC8H26O5Si4
Molecular Weight314.63 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)-4.0
CAS Registry Year (est.)1957

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