Roxithromycin Impurity 18 CAS 67796-27-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.67796-27-4
Molecular FormulaC4H10O3
Molecular Weight106.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roxithromycin Impurity 18 CAS 67796-27-4 chemical structure

Description

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.

As a process- or degradation-related impurity, Roxithromycin Impurity 18 (CAS 67796-27-4, C4H10O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Roxithromycin Impurity 18 (C4H10O3) 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.

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 FormulaC4H10O3
Molecular Weight106.12 g/mol
Purity97%+
StorageStore at 2-8°C, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)1976

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