535-0223-00L Pharmaceutical Analytics II
Semester | Autumn Semester 2017 |
Lecturers | C. Steuer |
Periodicity | yearly recurring course |
Language of instruction | German |
Abstract | This course provides the basic concepts of pharmaceutical analytics in the context of pharmacopeial regulation by Ph. Eur and Ph. helv. |
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, 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 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 |