Ambroxol Impurity 18 CAS 40525-78-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.40525-78-8
Molecular FormulaC6H13NO
Molecular Weight115.17 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ambroxol Impurity 18 CAS 40525-78-8 chemical structure

Description

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.

CATO supplies Ambroxol Impurity 18 (CAS 40525-78-8), a pharmacopoeial impurity reference standard (molecular formula C6H13NO, MW 115.17 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a hydroxyl group, an ether linkage, Ambroxol Impurity 18 is typically white to off-white liquid. Its solid-state physicochemical attributes — including a molecular weight of 115.17 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.

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 FormulaC6H13NO
Molecular Weight115.17 g/mol
Purity97%+
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)1.0
CAS Registry Year (est.)1968
Nitrogen Atoms1

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