This course provides the basic concepts of pharmaceutical analytics in the context of pharmacopeial regulation by Ph. Eur and Ph. Helv.
Learning objective
Students will be able to perform the following tasks: Explanation of the most important analytical techniques for the identification, purity testing and content determination of active pharmaceutical ingredients and excipients presented in Ph. Eur., USP, JP, andPh. Helv.) Analysis and spectral data interpretation of active pharmaceutical ingredients and excipients 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 spectroscopic methods, mass specetrometry and chromatographic techniques for qualification, identification, purity testing 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 Analytical/Pharmaceutical Analytics I/II or 36 credits of compulsory lectures 2nd year SR 2020: 7 credits Pharmaceutical Analytics I and II or 36 credits of compulsory lectures 2nd year
Performance assessment
Performance assessment information (valid until the course unit is held again)
Performance assessment as a semester course
: Special students and auditors need a special permission from the lecturers