FAKJ1_15 Selected Methods of Drug Quality Control

Faculty of Pharmacy
Autumn 2023
Extent and Intensity
1/0/0. 2 credit(s). Type of Completion: zk (examination).
Teacher(s)
doc. PharmDr. Ing. Radka Opatřilová, Ph.D., MBA (lecturer)
Guaranteed by
doc. PharmDr. Ing. Radka Opatřilová, Ph.D., MBA
Department of Chemical Drugs – Departments – Faculty of Pharmacy
Timetable
each even Wednesday 8:15–9:55 44-247
Prerequisites
FAKULTA(FaF) || OBOR(MUSFaF)
Lectures
Course Enrolment Limitations
The course is also offered to the students of the fields other than those the course is directly associated with.
fields of study / plans the course is directly associated with
Course objectives
Following a compulsory subject Drug Analysis this is to teach students the newest instrumental methods of drug quality control.

Selected instrumental methods, especially pharmacopoeial quality control and its application during tests of identity, purity and content determination of drugs and dosage forms.
Learning outcomes
Students are able to apply knowledge of good laboratory and manufacturing practice, students know the methods for sample preparation, know the extraction methods. Students are able to apply the methods of instrumental analysis in specific areas for the evaluation of toxicity, for methods of forensic chemistry, for ultratrace analysis, for biological methods of substance evaluation.
Syllabus
  • Lectures
    Introduction, good laboratory and manufacturing practices.
    Definitions, legislation, accredited laboratory (Examination of international regulations on drug production).
    Requirements for harmonization in terms of international controls
    Process validation
    Quality information and quality standards
    Good laboratory and good storage practices (GLP, GSP)
    Laboratory Safety
    Pharmacopoeial drug analysis
    Methods for sample preparation for analysis
    Specification of test and reference materials
    Sampling and storage of test and reference substance, storage conditions
    Disposal of analytical wastes
    Extraction of substances from the matrix (Liquid-liquid extraction, solid phase extraction
    Instrumental Methods Principles, methods sharing
    Miniaturization of analytical methods
    Tandem Technology
    Ultra-trace analysis
    Automatic Analyzers
    Biological methods for assessing the quality
    Methods of Forensic Chemistry
    Methods for evaluation of toxicity
    Patents.
Literature
  • European pharmacopoeia. info
Teaching methods
lectures
Assessment methods
written test
Language of instruction
English
Further comments (probably available only in Czech)
The course can also be completed outside the examination period.
Teacher's information
Written test
The course is also listed under the following terms Autumn 2020, Autumn 2021, Autumn 2022, Autumn 2024.
  • Enrolment Statistics (Autumn 2023, recent)
  • Permalink: https://is.muni.cz/course/pharm/autumn2023/FAKJ1_15