Colesevelam Impurity 7 CAS CATO-C4X-28397

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-28397
Molecular FormulaC18H42N4O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Colesevelam Impurity 7 CAS CATO-C4X-28397 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, Colesevelam Impurity 7 (CAS CATO-C4X-28397, C18H42N4OBr) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amide group, a hydroxyl group, an ether linkage, bromine substitution, Colesevelam Impurity 7 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 410.46 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC18H42N4O 2*Br
Molecular Weight410.46 g/mol
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)-0.5
Halogen ContentBr-containing
Nitrogen Atoms4

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