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: 28-09-2021


Duration: 1 semester

Version: Archive

Entry requirements

The course cannot be followed by students who have taken KE504: Analytical spectroscopy (5 ECTS).

Academic preconditions

Students taking the course are expected to have completed FA501, KE501, KE521 and KE538 and participate KE505 latest in the same period of time as this course.

Course introduction

The course aims to give the student knowledge of instrumental methods for qualitative and quantitative analysis so that the student is able to solve analytical problems, including critical evaluation of selected analytical technique, implementation of method development, optimization and validation, independent execution of data processing incl. to use statistical methods as well as clear and accurate reporting of analytical results in accordance with standards mentioned in guidelines (GLP, ICH, Ph.Eur.).

The course builds on the knowledge gained in the pharmacy introductory course (FA501) and the basic subjects in chemistry (KE501), physics (MM556) and mathematics (FY528) in the first year of study.
The course provides the academic basis for using instrumental analytical methods in the further study curriculum.

In relation to the competence profile of the degree it is the explicit focus of the course to:

  • 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

    The learning objectives of the course is that the student demonstrates the ability to:

    • 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

    The following main topics are contained in the course:

    • 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

    See tslearning for syllabus lists and additional literature references.

    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).

    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

    Indicative number of lessons

    90 hours per semester

    Teaching Method

    At the faculty of science, teaching is organized after the three-phase model ie. intro, training and study phase.
    In order to enable students to achieve the learning objectives for the course, the teaching is organised in such a way that there are 90 lectures, class lessons, etc. on a semester. These teaching activities are reflected in an estimated allocation of the workload of an average student as follows:

    •  Intro phase (lectures) - 28 hours
    • Training phase: 62 hours, including 34 hours tutorials, 24 hours laboratory, Demonstrations study: 3-5 hours.
      In addition, excursion 10 hours (one working day).
    Study phase:
    • 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.

    Teacher responsible

    Name E-mail Department
    Lars Porskjær Christensen lpc@sdu.dk Institut for Fysik, Kemi og Farmaci

    Additional teachers

    Name E-mail Department City
    Bala Krishna Prabhala bapra@sdu.dk Kemi og Farmaci
    Michael Petersen mip@sdu.dk Kemi og Farmaci

    Timetable

    Administrative Unit

    Fysik, kemi og Farmaci

    Team at Educational Law & Registration

    NAT

    Offered in

    Odense

    Recommended course of study

    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.