Methylnaltrexone Bromide Impurity 8 CAS CATO-C4X-15218

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-15218
Molecular FormulaC23H28NO5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Methylnaltrexone Bromide Impurity 8 CAS CATO-C4X-15218 chemical structure

Description

The occurrence of Methylnaltrexone Bromide Impurity 8 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Methylnaltrexone Bromide Impurity 8 (CAS CATO-C4X-15218) is a certified pharmaceutical impurity reference standard with the molecular formula C23H28NO5Br and a molecular weight of 478.38 g/mol.

Based on its molecular formula C23H28NO5Br, Methylnaltrexone Bromide Impurity 8 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 478.38 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC23H28NO5 Br
Molecular Weight478.38 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms1

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