Roxithromycin Impurity 14 CAS CATO-C4X-130314

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-130314
Molecular FormulaC4H9ClO3
Molecular Weight140.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roxithromycin Impurity 14 CAS CATO-C4X-130314 chemical structure

Description

As a process- or degradation-related impurity, Roxithromycin Impurity 14 (CAS CATO-C4X-130314, C4H9ClO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Roxithromycin Impurity 14 is typically white to off-white liquid. Its solid-state physicochemical attributes — including a molecular weight of 140.57 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 certified reference material (CRM), Roxithromycin Impurity 14 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC4H9ClO3
Molecular Weight140.57 g/mol
Purity97%+
StorageStore at 2-8°C, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityHygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)0.0
Halogen ContentCl-containing

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