Erythromycin Impurity 26 CAS 13483-18-6

Purity >80%In StockPharmacopoeial Impurity Standards
CAS No.13483-18-6
Molecular FormulaC4H8Cl2O2
Molecular Weight159.01 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Erythromycin Impurity 26 CAS 13483-18-6 chemical structure

Description

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.

As a process- or degradation-related impurity, Erythromycin Impurity 26 (CAS 13483-18-6, C4H8Cl2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Erythromycin Impurity 26 (C4H8Cl2O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 0.0, corresponding to approximately 0 ring(s) or double-bond equivalent(s). With a molecular weight of 159.01 g/mol, it falls into the medium-molecular-weight range. 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.

Physical & Chemical Properties

Molecular FormulaC4H8Cl2O2
Molecular Weight159.01 g/mol
Purity>80%
StorageStore at 2-8°C, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityContains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)1960
Halogen ContentCl-containing

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