Abstract
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.
Highlights
During the last century, pharmacy and the pharmaceutical industry have developed at a truly breath-taking pace, from small pharmacies and dispensaries to multibillion-dollar global companies.Besides the famous research in and development of new drugs, commonly referred to as R&D, drug safety increasingly takes centre stage
It is common to carry out a series of different analyses to achieve a sufficient characterization of the sample and identification of all hints for an impurity found in the sample, such as a spot on the thin layer chromatography (TLC) or a peak in the mass spectrum, often with the assistance of modern and automated methods of characterization
We have demonstrated that the issue of impurities in medications is complicated and involves aspects of chemistry, biology, drug safety, and analytical power, and epistemology and ethics
Summary
Pharmacy and the pharmaceutical industry have developed at a truly breath-taking pace, from small pharmacies and dispensaries to multibillion-dollar global companies. The prime focus in treating a medical condition is geared toward guaranteeing safety and comfort of and for the patient This stipulates for high-quality medications and treatments accompanied by flawless manufacturing regulations and strategies. The thalidomide scandal, for instance, remains to this day a subject of scientific, philosophical, social, and legal scrutiny [4,5,6] This case in the 1960s raised immense awareness about the differences in biological activities of racemate compounds and shaped the current ethics of chemical synthesis. It inevitably influenced drug development processes and regulation. The remaining 2.5% mass is composed of various impurities is shown on the side of the container or listed in typical data sheets accompanying such a sample
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