Analyse et contrôle de qualité des médicaments

wfarm2117  2022-2023  Bruxelles Woluwe

Analyse et contrôle de qualité des médicaments
3.00 credits
30.0 h
Main themes
The main methods and norms used for purity and quality control of drugs (qualitative and quantitative analysis of impurities, assays,') will be explained
Learning outcomes

At the end of this learning unit, the student is able to :

1 - Give to the student the appropriate knowledge:
  1. to  use efficiently reference documents (e.g. pharmacopoeias) for quality control of a medicine or its constituents, including understand the methods described in such documents
  2. to allow the student to choose the most adequate analytical method to solve a given problem in drug analysis (mixture of active molecules, related substances,')
  1. Drugs quality control  Pharmacopoeia : general aspects
  2. Purity of drugs and main degradation pathways
  3. Identification methods (infra red spectroscopy, nuclear magnetic resonance)
  4. General identification reactions
  5. Separation methods (liquid-liquid and solid-liquid extractions, liquid, supercritical and gaz chromatographies, electrophoresis).
  6. Quantification methods and validation of analytical methods
  7. Introduction to mass spectrometry (MS), coupling of MS with separation methods
  8. Tests
  9. General monographs
  10. Discussion of monographs
  11. Examples of the main routes of chemical and physical degradation of a drug
  12. Control of commercialised medicines
Teaching methods
Teaching method: in part, theoretical teaching except exceptional sanitary measures, as well as group work of students and reverse classes.
Evaluation methods
Evaluation by a written exam and exercises
Other information
The basic principles of analytical methods are not addressed in this EU. These concepts are widely discussed in the BAC EU (e.g. WFARM1243, WFARM1312, WFARM1219). Students are strongly encouraged to review the course materials if they find weaknesses in their bachelor's degree training.
Online resources
used supports are descibed on Moodle
Teaching materials
  • une version des supports présentés est disponible sur moodle
  • Pharmacopée Européenne
Faculty or entity

Programmes / formations proposant cette unité d'enseignement (UE)

Title of the programme
Learning outcomes
Master [120] in Pharmacy