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Impact of Metal-induced Degradation on the Determination of Pharmaceutical Compound Purity and a Strategy for Mitigation by Sally K. Dotterer; Robert A. Forbes; Cynthia L. Hammill is a Chemistry article available to read on EtoBox.

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Case studies are presented demonstrating how exposure to traces of transition metals such as copper and/or iron during sample preparation or analysis can impact the accuracy of purity analysis of pharmaceuticals. Some compounds, such as phenols and indoles, react with metals in the presence of oxygen to produce metal-induced oxidative decomposition products. Compounds susceptible to metal-induced decomposition can degrade following preparation for purity analysis leading to falsely high impurity results. Our work has shown even metals at levels below 0.1 ppm can negatively impact susceptible compounds. Falsely low results are also possible when the impurities themselves react with metals and degrade prior to analysis. Traces of metals in the HPLC mobile phase can lead to chromatographic artifacts, affecting the reproducibility of purity results. To understand and mitigate the impact of metal induced decomposition, a proactive strategy is presented. The pharmaceutical would first be tested for reactivity with specific transition metals in the sample solvent/diluents and in the HPLC mobile phase. If found to be reactive, alternative sample diluents and/or mobile phases with less reac

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Author

Sally K. Dotterer; Robert A. Forbes; Cynthia L. Hammill

Publisher

Elsevier Science; Elsevier ; Elsevier BV (ISSN 0731-7085)

Published

2011

Language

EN

Field

Chemistry (Physical Sciences)