A Simplified Determination of 2-Ethylhexanoic Acid in Clavulanate
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The determination method is outlined in Application Note 262: Determination of 2-Ethylhexanoic Acid Impurity in Clavulanate and reports results for limit of detection/limit of quantification (LOQ/LOQ), linear calibration range, spike recovery, retention time precision, and peak area precision determinations that show this to be an accurate and reproducible technique to determine 2-ethylhexanoic acid in clavulanate below the 0.8% acceptance criteria.
The methodology in Application Note 262 uses a Dionex Reagent-Free™ Ion Chromatography (RFIC™) system and direct injection onto an IonPac® AS11 column without additional sample pretreatment. This approach uses 150-fold lower concentration of the API and eliminates the need for solvent extraction per the current United States Pharmacopeia (USP) monograph, thus consuming less of the API and simplifying sample preparation.
The methodology in Application Note 262 uses a Dionex Reagent-Free™ Ion Chromatography (RFIC™) system and direct injection onto an IonPac® AS11 column without additional sample pretreatment. This approach uses 150-fold lower concentration of the API and eliminates the need for solvent extraction per the current United States Pharmacopeia (USP) monograph, thus consuming less of the API and simplifying sample preparation.
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