Ambroxol Impurity 12 CAS 23363-88-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.23363-88-4
Molecular FormulaC8H15NO2
Molecular Weight157.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ambroxol Impurity 12 CAS 23363-88-4 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.

CATO supplies Ambroxol Impurity 12 (CAS 23363-88-4), a pharmacopoeial impurity reference standard (molecular formula C8H15NO2, MW 157.21 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C8H15NO2, Ambroxol Impurity 12 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 157.21 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 FormulaC8H15NO2
Molecular Weight157.21 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1963
Nitrogen Atoms1

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