Acesulfame potassium EP Impurity A CAS 5977-14-0

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.5977-14-0
Molecular FormulaC4H7NO2
Molecular Weight101.10 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Acesulfame potassium EP Impurity A CAS 5977-14-0 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Acesulfame potassium EP Impurity A.

Acesulfame potassium EP Impurity A (CAS 5977-14-0) is a certified pharmaceutical impurity reference standard with the molecular formula C4H7NO2 and a molecular weight of 101.10 g/mol.

The molecular framework of Acesulfame potassium EP Impurity A (C4H7NO2) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 FormulaC4H7NO2
Molecular Weight101.10 g/mol
Purity>90%
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.)1958
Nitrogen Atoms1

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