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"Impurities in Drug Substances
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and Drug Products"
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Workshop (18-March-2010)
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Hotel alfa, Birsfelden (Basel), Switzerland
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Speakers:
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Dr. Ralph Nussbaum, Chemist (Analytical Services)
Dr. Jochen Kirschbaum, Chemist (Analytical Services)
Dr. Helmut Buschmann, Chemist (Pharma Consulting Aachen)
Dr. Theo Matthiesen, Toxicologist (Pharma Consulting Aachen)
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Impurities are unknown by- or degradation products in drug substances and drug products. They occur during early phase development as well as during stability studies or in new formulations.
They are formed due to manifold reasons, e.g. change of a synthetic route, interaction with excipients, polymorphic conversion etc. . If the impurity level exceeds a certain threshold, the structure of this impurity has to be elucidated or it has to be toxicologically qualified.
In connection with the structure elucidation the synthesis of the impurity with subsequent qualification as a reference standard is required.
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