Syllabus
Lectures
The pharmaceutical analysis -definition, main areas of its utilization, Pharmacopoeias
Regulatory authorities (FDA, EME, ICH)
Quality control and quality assurance in the pharmaceutical industry
Identification of pharmaceutical compounds based on their physical-chemical constants (e.g. melting point, distillation range, density, refractive index, optical rotation)
Spectral methods in pharmaceutical analysis (UV, IR)
Chromatographic methods in the identification of APIs and pharmaceutical products (HPLC, TLC, GC)
Identification of pharmaceutical compounds using chemical reactions
General and selective chemical reactions used for the identification of pharmaceutical compounds
Testing of purity in the pharmaceutical analysis
Limit tests for pharmaceutical compounds based on chemical reactions
Limit tests for pharmaceutical compounds based on instrumental methods
Seminars & Practical training
Practical use of the Pharmacopoeia for analytical evaluation of pharmaceutical compounds
Calculations of the content of API and purity tests limits
Analytical evaluation of selected pharmaceutical compounds according to the Pharmacopoeia
Identification of pharmaceutical compounds using physico-chemical constants and the chemical reactions
Purity testing of pharmaceutical compounds (chemical methods, using selected physical constants)
General principle of volumetric assay according to the Pharmacopeia
Volumetric assay of selected pharmaceutical compounds in nonaqueous media
Annotation
Pharmaceutical analysis belongs among the profile subjects taught at the faculty and is part of the state examination. Within the theoretical and practical teaching, the main attention is paid to the issues of management of quality, safety and efficacy of pharmaceuticals, which inevitably fulfills one of the basic functions of pharmaceutical study.
The starting point for choice the appropriate method for both identification and quantitative analysis is the structure of the drug. The two-semester course follows the basic knowledge gained in the preparatory subjects of Inorganic Chemistry, Organic Chemistry, Analytical Chemistry and Instrumental Methods.
Emphasis is placed on the use of analytical methods in the control-analytical evaluation of pharmaceuticals and pharmaceutical excipients. The teaching is based on the valid European Pharmacopoeia as a basic normative regulation.
As part of the Pharmaceutical Analysis I, students learn first the basic procedures and methods used for pharmacopoeial identity verification, purity assessment, and content determination of official pharmacopoeial substances. Besides the European Pharmacopoeia, students are further acquainted with other world-renowned pharmacopoeial monographs (USP, JP, BP).
Pharmaceutical Analysis II is focused primarily on the use of instrumental methods in analyzing not only APIs (Active Pharmaceutical Ingredients) but also pharmaceutical preparations. Attention is also paid to the evaluation of drug stability, the development of a suitable analytical method, questions on the enantiomeric purity of drugs and also to the basic aspects of the determination of drugs in biological material.
Students are further acquainted with the basics of Good Laboratory Practice and Good Manufacturing Practice. During the practical lessons, each student has a pharmacopoeia available to learn a quick orientation in a large amount of factual data.