Esomeprazole impurity 127 CAS 16282-23-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.16282-23-8
Molecular FormulaC7H9NO2
Molecular Weight139.15 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Esomeprazole impurity 127 CAS 16282-23-8 chemical structure

Description

The occurrence of Esomeprazole impurity 127 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Esomeprazole impurity 127 (CAS 16282-23-8, C7H9NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Esomeprazole impurity 127 is typically off-white to pale yellow liquid. Its solid-state physicochemical attributes — including a molecular weight of 139.15 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.

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 FormulaC7H9NO2
Molecular Weight139.15 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1961
Nitrogen Atoms1

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