EVALUATION OF AN ION EXCLUSION/DIRECT CONDUCTIVITY METHOD FOR QUANTITATING ACETIC AND LACTIC ACIDS IN PHARMA-CEUTICAL LVP BASE FORMULATIONS

Abstract

Organic acids (e.g., acetic, lactic and gluconic acid) are common components in Large Volume Parenteral (LVP) base solutions. The characterization of such solution products is necessary for production control and product release. A chromatographic method, which couples separation by anion exclusion with direct conductivity detection, has been developed for this purpose. The evaluation of this method, carried out in a manner consistent with United States Pharmacopeia (USP) and International Council for Harmonization (ICH) guidelines, is summarized in this manuscript. The method meets the acceptance criteria for in-process and/or product release testing with respect to accuracy, linearity, range, precision, and specificity.

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