This course provides the basic concepts of pharmaceutical analytics in the context of pharmacopeial regulation. After an introduction to the fundamental techniques and concepts, the participants will study independently, apply and consolidate their knowledge in tutorials.
Learning objective
Students are able to: summarize the structure of the Ph. Eur. summarize the most important pharmacopeias and their communalities and differences discuss the structure of a monograph explain qualification of instruments and validation of methods explain and compare most important analytical techniques for pharmaceutical industry
Content
Students gain knowledge in pharmaceutical analytics to fulfill regulatory requirements 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
Slides, see documents repository
Literature
Introduction to Pharmaceutical Chemical Analysis, Steen Honoré Hansen, Stig Pedersen-Bjergaard, Knut Rasmussen ISBN: 978-0-470-66121-5 , DOI: 10.1002/9781119953647, free download for eth students
Performance assessment
Performance assessment information (valid until the course unit is held again)
Performance assessment as a semester course