535-0224-00L  Pharmaceutical Analytics II

SemesterSpring Semester 2019
LecturersC. Steuer
Periodicityyearly recurring course
Language of instructionGerman

AbstractThis course provides the basic concepts of pharmaceutical analytics in the context of pharmacopeial regulation by Ph. Eur and Ph. helv.
ObjectiveSummarize 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
ContentKnowledge 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, purity testing and content determination of active pharmaceutical ingredients and excipients.
Lecture notesThe slides of the lectures will be provided
LiteratureInstrumentelle 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 / NoticeRequirements for the practical course Pharmaceutical Analytics:
SR 2004: 2 credits Analytical Chemistry (529-1041-00), lecture Pharmaceutical Analytics
SR 2013: 6 credits Analytics/Pharmaceutical Analytics or 36 credits of compulsory lectures 2nd year