Analyse et contrôle de qualité des médicaments [ WFARM2117 ]

• Organic chemistry
• Introduction to analytical chemistry, instrumental analysis

The main methods and norms used for purity and quality control of drugs (qualitative and quantitative analysis of impurities, assays,') will be explained

- 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,')

Evaluation by a written exam and exercises

Teaching method: theoretical teaching

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