511-1002-00L  Pharmaceutical Analytics and Pharmacopeia (Crash Course)

SemesterAutumn Semester 2020
LecturersC. Steuer
Periodicityyearly recurring course
Language of instructionEnglish
CommentOnly for Pharmaceutical Sciences MSc.

Obligatory course if assigned by the Admission committee.

AbstractThis 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.
ObjectiveStudents 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
ContentStudents 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 notesSlides, see documents repository
LiteratureIntroduction 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