AN262: Determination of 2-Ethylhexanoic Acid Impurity in Clavulanate
DescriptionClavulanic acid is a potent beta-lactamase inhibitor. 2-ethylhexanoic acid is a potential impurity. This work presents a simpler IC method using a Reagent-Free Ion Chromatography (RFIC) system with suppressed conductivity detection and IonPac AS11 column for the detection and quantification of 2-ethylhexanoic acid. Results for LOD/LOQ, linear calibration range, spike recovery, retention time precision, and peak area precision determinations show that IC is an accurate and reproducible technique to determine 2-ethylhexanoic acid in clavulanate below the 0.8% acceptance criteria.
|Keywords:||2-ethylhexanoic acid, Active pharmaceutical ingredient (API), Anion-exchange, beta-lactamase inhibitor, Ion chromatography, IonPac AS11, Pharmaceutical, Potassium clavulanate, RFIC, Suppressed conductivity|
|Author:||Richard Kornfeld, Brian De Borba, Jeffrey Rohrer|
For Research Use Only. Not for use in diagnostic procedures.