FA507: Instrumental pharmaceutical analysis
Study Board Pharmacy
Teaching language: Danish or English depending on the teacher
EKA: N560024112, N560024122, N560024102
Assessment: Second examiner: None, Second examiner: External
Grading: Pass/Fail, 7-point grading scale
Offered in: Odense
Offered in: Spring
Level: Bachelor
STADS ID (UVA): N560024101
ECTS value: 10
Date of Approval: 12-10-2023
Duration: 1 semester
Version: Approved - active
Comment
The course is partly co-taught with KE530: Quantitative Analytical Chemistry and K-PTE4-U1 offered by Department of Green Technology (IGT).
Entry requirements
The course cannot be followed by students who have taken KE504: Analytical spectroscopy (5 ECTS), og KE530.
Academic preconditions
Students taking the course are expected to have completed FA501, KE501, KE521 and KE538 and participate in KE505 in the same period of time as this course at the latest.
Course introduction
The purpose of the course is for the student to gain knowledge of instrumental methods for qualitative and quantitative analysis, so that the student is able to solve analytical problems, including critical assessment of chosen analysis technique, implementation of method development, optimization and validation, independent execution of data processing incl. to use statistical methods and clear and precise reporting of analytical results. In addition, the student must know and apply analytical guidelines (GLP, ICH, Ph.Eur.) and assess relevant professional literature.
The course builds on the knowledge acquired in the basic pharmacy course (FA501) and the basic subjects in chemistry (KE501), physics (FY528) and mathematics (MM556) in the first year of study.
The course provides the professional basis for using instrumental analytical methods in further studies.
In relation to the education's competence profile, it is the explicit focus of the course to:
- provide competence to critically assess and apply analytical instrumental methods to solve analytical pharmaceutical problems (qualitative and quantitative) and to take into account official monographs (e.g. Ph.Eur.), guidelines (ICH, GLP) and scientific literature,
- provide skills to perform and optimize analytical methods, to perform structural analysis and quantitative determination (calibration, standards), to calculate validation parameters (including precision, accuracy, selectivity, detection limit, quantification limit, separation and column parameters), to use statistical methods in data processing, and to report test results in easy-to-understand, precise and correct language,
- provide knowledge of central 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 methods.
- know the safety aspects of laboratory work in a chemical analysis laboratory
- be able to use statistical tools and methods
- demonstrate familiarity with scientific methods for correct data processing, presentation and interpretation
Expected learning outcome
In order to achieve the purpose of the course, the learning objective for the course is for the student to demonstrate the ability to:
- be able to critically assess and apply analytical instrumental methods to solve qualitative and quantitative analytical pharmaceutical problems and to take into account official monographs (Ph.Eur.) and guidelines (ICH, GLP) as well as scientific literature (competences),
- be able to perform and optimize analytical methods, perform quantitative determination (calibration, standards), calculate validation parameters including precision, accuracy, selectivity, detection limit, quantification limit, separation and column parameters, use statistical methods and report test results in easy-to-understand, precise and correct language (skills) and
- know central concepts and principles of the analytical process (validation, statistical analysis methods), spectroscopic methods incl. for structural analysis (UV/Vis, fluorescence, IR, NMR, MS), chromatographic separation methods (HPLC, TLC, GC, SEC, electrophoresis) as well as coupling separation methods with common detection methods (knowledge). Make a critical assessment of a given analysis technique with focus on optimization and validation
- Interpret results using statistical analyses and tests
- Carry out analyses using HPLC and GC
- Work sensibly and safely in an analytical chemistry laboratory
Content
The course contains the following main subject areas:
- General chromatographic concepts as well as method development, optimization and validation. Influence of the mobile and stationary phases, as well as column selection
- Chromatographic separation methods (HPLC, TLC, GC, SEC, electrophoresis)
- Spectroscopic methods incl. for structural analysis (UV/Vis, fluorescence, IR, NMR, MS)
- Quantification principles
- Statistical distribution functions and probability
- Hypothesis testing of one or two variables (t-test and paired t-test)
- One-way and multi-way analysis of variance
- Linear regression analysis
- Experimental trial design
- Method validation and statistical analyses
- Uncertainty budgets
- GLP (Good Laboratory Practice)
- Definition of national and international standards
- Definition of accreditation and certification
- Definition of GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice) and other Good Practices
Literature
Examination regulations
Prerequisites for participating in the exam a)
Timing
Spring
Tests
Participation in lab exercises and E-hours
EKA
N560024112
Assessment
Second examiner: None
Grading
Pass/Fail
Identification
Full name and SDU username
Language
Normally, the same as teaching language
Examination aids
To be announced during the course.
ECTS value
0
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 prerequisite examination is a prerequisite for participation in exam element a) og b).
Exam element a)
Timing
Spring
Prerequisites
| Type | Prerequisite name | Prerequisite course |
|---|---|---|
| Examination part | Prerequisites for participating in the exam a) | N560024101, FA507: Instrumental pharmaceutical analysis |
Tests
Reports and exercises
EKA
N560024122
Assessment
Second examiner: None
Grading
Pass/Fail
Identification
Full name and SDU username
Language
Normally, the same as teaching language
Examination aids
To be announced during the course.
ECTS value
2
Exam element b)
Timing
June
Prerequisites
| Type | Prerequisite name | Prerequisite course |
|---|---|---|
| Examination part | Prerequisites for participating in the exam a) | N560024101, FA507: Instrumental pharmaceutical analysis |
Tests
Written examination
EKA
N560024102
Assessment
Second examiner: External
Grading
7-point grading scale
Identification
Full name and SDU username
Language
Normally, the same as teaching language
Duration
4 hours
Examination aids
All common aids are allowed e.g. books, notes and computer programmes which do not use internet etc.
Internet is not allowed during the exam. However, you may visit the course site in itslearning to fill in the MCQ test and to open system "DE-Digital Exam". If you wish to use course materials from itslearning, you must download the materials to your computer no later than the day before the exam. During the exam you cannot be sure that all course materials is accessible in itslearning.
ECTS value
8
Additional information
With 10 or fewer students, the format of the rexam will be an oral exam.
Indicative number of lessons
Teaching Method
- Intro phase: 20 hours
- Training phase: 56 hours of which Examinatory class: 44 hours; laboratory exercises: 12 hours
- Study phase: Self-study of the textbook and other relevant literature, especially for post-work on lectures and the preparation for laboratory and E-hours Assignments, data analysis and report writing. Continuous collection and review of learning materials and course topics.
Teacher responsible
| Name | Department | |
|---|---|---|
| Lars Porskjær Christensen | lpc@sdu.dk | Institut for Fysik, Kemi og Farmaci |
| Rime Bahij | rimb@igt.sdu.dk | Institut for Grøn Teknologi |
Additional teachers
| Name | Department | City | |
|---|---|---|---|
| Bala Krishna Prabhala | bapra@sdu.dk | Kemi og Farmaci | |
| Jose Bonilla | jobo@igt.sdu.dk | Institut for Grøn Teknologi | |
| Michael Petersen | mip@sdu.dk | Kemi og Farmaci | |
| Muhammad Tahir Ashraf | muta@igt.sdu.dk | Institut for Grøn Teknologi |
Timetable
Administrative Unit
Team at Educational Law & Registration
Offered in
Recommended course of study
| Profile | Education | Semester | Offer period |
|---|---|---|---|
| BSc major in Pharmacy - Registration 1 September 2020, 2021, 2022 and 2023 | Bachelor of Science (BSc) in Pharmacy | Odense | 4 | E23 |
Transition rules
Transitional arrangements describe how a course replaces another course when changes are made to the course of study.
If a transitional arrangement has been made for a course, it will be stated in the list.
See transitional arrangements for all courses at the Faculty of Science.