This course provides the basic concepts of pharmaceutical analytics in the context of pharmacopeial regulation by Ph. Eur and Ph. Helv.
Learning objective
Summarize the structure of the Ph. Eur. Summarize the most important pharmacopeias and their commonalities and differences (USP, JP, Ph.Eur., Ph. Helv.) Discuss the structure of a monograph Explain qualification of instruments and validation of methods Explain and compare most important analytical techniques for pharmacies and pharmaceutical industry
Content
Knowledge in pharmaceutical analytics to fulfill regulatory equirements in pharmaceutical industry based on the pharmacopeia in force. Focus is set on method validation, equipment qualification, identification of functional groups and content determination of active pharmaceutical ingredients and excipients.
Lecture notes
The slides of the lectures will be provided.
Literature
Instrumentelle Analytik, G. Rücker, M. Neugebauer, G.G. Willems; Deutscher Apotheker Verlag, Stuttgart Arzneistoffanalyse; H. J. Roth, K. Eger, R. Troschütz; Deutscher Apotheker Verlag, Stuttgart Introduction to Pharmaceutical Chemical Analysis; S.H. Hansen, S. Pedersen-Bjergaard, K. Rasmussen; Wiley & Sons
Prerequisites / Notice
Requirements for the practical course Pharmaceutical Analytics: SR 2013: 6 credits Analytics/Pharmaceutical Analytics or 36 credits of compulsory lectures 2nd year SR 2020: 7 credits Pharmazeutische Analytik I und II or 36 credits of compulsory lectures 2nd year