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AN262: Determination of 2-Ethylhexanoic Acid Impurity in Clavulanate Be the first to rate this application

an262 determination 2ethylhexanoic acid impurity clavulanate


Clavulanic 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.
Market: Pharma
Keywords: 2-ethylhexanoic acid, Active pharmaceutical ingredient (API), Anion-exchange, beta-lactamase inhibitor, Ion chromatography, IonPac AS11, Pharmaceutical, Potassium clavulanate, RFIC, Suppressed conductivity
Matrix: Drug
Author: Richard Kornfeld, Brian De Borba, Jeffrey Rohrer
Uploaded on 8/24/2015.

For Research Use Only. Not for use in diagnostic procedures.