
FA507: Instrumental pharmaceutical analysis
Entry requirements
Academic preconditions
Students taking the course are expected to have completed FA501, FF503, KE521 and KE538 and participate KE505 latest in the same period of time as this course.
Course introduction
- give the competence to critically evaluate and use different analytical methods to solve quantitative and qualitative issues according to official monographs (e.g. Ph.Eur.) and guidelines (ICH, GLP) as well as relevant scientific literature.
- acquire skills to perform and optimize analytical methods, to perform structural, qualitative and quantitative analysis (calibration, standards) to calculate validation parameters (including precision, accuracy, selectivity, detection limit, quantification limit, separation and column parameters) and use statistical methods in data processing to report experimental results in easy-to-understand language.
- give knowledge on key concepts and principles of the analytical process (validation, statistical analysis methods), spectroscopic methods incl. structural analysis (UV / Vis, fluorescence, IR, NMR, MS), chromatographic separation methods (HPLC, TLC, GC, SEC, electrophoresis) and coupling of separation methods with common detection.
Expected learning outcome
- be able to critically evaluate and use analytical instrumental methods to solve qualitative and quantitative analytical pharmaceutical issues and to take into account official monographs (Ph. Eur.), guidelines (ICH, GLP) and scientific literature (competencies).
- be able to perform and optimize analytical methods, use spectroscopic methods for qualitative analysis (structural analysis), perform quantitative determination (calibration, standards), calculate validation parameters including precision, accuracy, selectivity, detection limit, quantification limit, separation and column parameters, using statistical methods test results in easily understandable, accurate and correct language (skills).
- know key concepts and principles of the analytical processes (validation, statistical analysis methods), spectroscopic methods incl. for structural analysis (UV / Vis, fluorescence, IR, NMR, MS), chromatographic separation methods (HPLC, TLC, GC, SEC, electrophoresis) and coupling of separation methods with common detection methods (knowledge).
Content
- Fundamentals of philosophy of science and scientific methods
- Instrumental analysis in the pharmaceutical sciences and GMP
- The analytical process (GLP, systematic and random errors, qualification and validation, statistical methods, guidelines such as GLP and ICH, sample preparation),
- Quantitative and qualitative analysis in the pharmaceutical science
- Spectroscopic methods (UV / Vis, fluorescence, IR, NMR, MS), principles, instrumentation and application in the pharmaceutical science
- Chromatographic methods (HPLC, TLC, GC, SEC, electrophoresis) as well as their common detection methods, principles, instrumentation and application in the pharmaceutical science
- Structural analysis by IR, NMR and MS
- Quantitative analysis (calibration, internal and external standard, selectivity)
Literature
Examination regulations
Prerequisites for participating in the exam a)
Timing
Tests
Participation in lab exercises and E-hours
EKA
Assessment
Grading
Identification
Language
Examination aids
To be announced during the course.
Allowed/Not allowed. A closer description of the exam rules will be posted under 'Course Information' on Blackboard.
ECTS value
Additional information
Participation in lab exercises and E-hours (at least 80 % for both). The prerequisite examination is a prerequisite for participation in exam element a) og b).
The examination form for re-examination may be different from the exam form at the regular exam.
Exam element a)
Timing
Prerequisites
Type | Prerequisite name | Prerequisite course |
---|---|---|
Prerequisite not found |
Tests
Reports and exercises
EKA
Assessment
Grading
Identification
Language
Examination aids
To be announced during the course.
Allowed/Not allowed. A closer description of the exam rules will be posted under 'Course Information' on Blackboard.
ECTS value
Additional information
Exam element b)
Timing
Prerequisites
Type | Prerequisite name | Prerequisite course |
---|---|---|
Prerequisite not found |
Tests
Written examination
EKA
Assessment
Grading
Identification
Language
Duration
Examination aids
Allowed, a closer description of the exam rules will be posted in itslearning.
ECTS value
Additional information
Indicative number of lessons
Teaching Method
- Self-study of the textbook and other relevant literature especially with respect to work with theory from the lectures and to prepare for the seminars and laboratory exercises.
- Exercises, data analysis and report writing
- Continuous work and repetition of course materials and topics