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Open AccessArticle

Chemical Impurities: An Epistemological Riddle with Serious Side Effects

Division of Bioorganic Chemistry, School of Pharmacy, Saarland University, D-66123 Saarbruecken, Germany
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Int. J. Environ. Res. Public Health 2020, 17(3), 1030; https://doi.org/10.3390/ijerph17031030
Received: 25 December 2019 / Revised: 22 January 2020 / Accepted: 1 February 2020 / Published: 6 February 2020
(This article belongs to the Special Issue Societal Side Effects: The Wider Impact of Pharmaceuticals on Society)
Chemical synthesis is a science and an art. Rooted in laboratory or large-scale manufacture, it results in certain side products, eventually compromising the integrity of the final products. Such “impurities” occur in small amounts and, within chemistry itself, are of little concern. In pharmacy, in contrast, impurities increase the potential for toxicity, side effects, and serious implications for human health and the environment. The pharmaceutical regulatory agencies have therefore developed regulatory and strategic systems to minimize the chemical presence or biological impact of such substances. Here, pharmaceuticals are turned from impure into more defined materials as part of a complex socio-technological system revolving around and constantly evolving its specific rules and regulations. Whilst modern analytical methods indicate the presence of impurities, the interpretations of corresponding results are gated by risk management and agreed thresholds. Ironically, this allows for entities with no identified chemical structures, and hence epistemologically outside chemistry, to be regulated in pharmaceutical products. We will refer to such substances which are not, epistemologically speaking, “chemicals” as Xpurities, in order to distinguish them from recognized and identified impurities. The presence of such Xpurities is surprisingly common and constitutes a major issue in pharmaceutical research and practice. We propose a Space of Information to deal with such impurities based on values regarding the presence, chemical identities, and biological activities. It is anticipated that this may enable pharmacists to handle such Xpurities more efficiently. View Full-Text
Keywords: epistemology; impurity; pharmaceutical; risk management; space of information; Xpurity epistemology; impurity; pharmaceutical; risk management; space of information; Xpurity
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Abdin, A.Y.; Yeboah, P.; Jacob, C. Chemical Impurities: An Epistemological Riddle with Serious Side Effects. Int. J. Environ. Res. Public Health 2020, 17, 1030.

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