SubjectsSubjects(version: 964)
Course, academic year 2024/2025
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Drug Analysis - GBN026
Title: Analýza chemických léčiv
Guaranteed by: Department of Pharmaceutical Chemistry and Pharmaceutical Analysis (16-16190)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2022
Semester: winter
Points: 0
E-Credits: 6
Examination process: winter s.:oral
Hours per week, examination: winter s.:28/56, C+Ex [HS]
Capacity: unlimited / unlimited (unknown)
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: taught
Language: Czech
Teaching methods: full-time
Level:  
Explanation: 2.ZBN - akreditace
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: doc. PharmDr. Radim Kučera, Ph.D.
Comes under: 2.ročník 2023/24 BLDZ volitelné
Annotation -
The structure of drug is the key point for the choice of the appropriate analytical technique. The subject Analysis of chemical drugs provides theoretical and practical knowledge concerning the principles of quality assurance, safety and efficacy of pharmaceuticals. The course is baased not only on the current Czech and European Pharmacopoeia but it reflects also other modern pharmacopoeial monographs (e.g.The United States Pharmacopoeia). It also addresses other areas such as drug analysis in biological materiál, etc.
Last update: Kučera Radim, doc. PharmDr., Ph.D. (02.09.2024)
Course completion requirements -

Credit Requirements

  • Presence at all practical trainings - excused practical classes might be passed during the extra lesson

  • knowledge of discussed topics, Pharmacopoeia knowledge

  • Approved reports from all practical tasks

 

Exam

Last update: Kučera Radim, doc. PharmDr., Ph.D. (02.09.2024)
Literature - Czech

Doporučená:

  • Klimeš, Jiří. Kontrolně-analytické hodnocení léčiv lékopisnými metodami. Hradec Králové: NECLEUS HK, 2011, 265 s. ISBN 978-80-87009-29-1.

Last update: prepocet_literatura.php (19.09.2024)
Teaching methods -
Lectures, seminars, practical classes.
Last update: Kučera Radim, doc. PharmDr., Ph.D. (02.09.2024)
Requirements to the exam - Czech

Analýza chemických léčiv – tematické okruhy ke zkoušce

 

  1. Důkazy léčiv s využitím fyzikálních konstant

  2. Důkazy léčiv s využitím UV-VIS spektrometrie

  3. Důkazy léčiv s využitím IČ spektrometrie

  4. Důkazy léčiv chemickými reakcemi, obecné reakce a důkazy

  5. Chemické důkazy vybraných strukturních typů léčiv

  6. Využití kapalinové chromatografie v lékopisné kontrole léčiv

  7. Využití spektrálních metod v lékopisné kontrole léčiv

  8. Lékopisné metody kvantitativního hodnocení léčiv

  9. Limitní zkoušky na čistotu léčiv

  10. Využití plynové chromatografie v lékopisné kontrole léčiv

  11. Chemické zkoušky na čistotu léčiv

  12. Zkoušky na čistotu léčiv s využitím TLC a HPLC

  13. Faktory ovlivňující stabilitu léčiv, zátěžové zkoušky

  14. Zrychlené a dlouhodobé stabilitní testy léčivých přípravků

  15. Lékopisné titrační metody pro stanovení léčiv

  16. Stanovení léčivých látek acidimetrickými titracemi

  17. Stanovení léčivých látek alkalimetrickými titracemi

  18. Validace metod pro kontrolně-analytické účely

  19. Vývoj metod pro hodnocení API a léčivých přípravků

  20. Analýza chirálních molekul

  21. Možnosti využitím hmotnostní spektrometrie v analýze léčiv

 

Last update: Kučera Radim, doc. PharmDr., Ph.D. (02.09.2024)
Syllabus -

Lectures

Drug Identification

Detection of drugs using physical constants,  physicochemical methods (spectral, separational methods) and chemical methods

Group and selective reactions of individual structural types of drugs of important pharmacotherapeutic groups (analgesics-antipyretics, analgesics-anodynes, sedatives, anaesthetics, hypnotics, psychopharmaceuticals, analeptics, local anaesthetics, myorelaxants,etc.)

Tests on the purity of drugs (chemical tests chromatographic and spectral methods)

Determination of drug content (Pharmacopoeia Methods of Quantitative Analysis) APIs and Medicinal Products

Stability studies of pharmaceuticals

Development of methods for drug analysis

Chiral analysis

Seminars and Practical training

Analytical evaluation of pharmaceuticals using pharmacopoeia

Identification of the drug using physico-chemical constants, chemical reactions, physicochemical methods

Tests on the purity of drugs (chemical evidence of impurities, evidence of impurities or degradation products by chromatographic and spectral methods)

Determination of drug content (pharmacopoeial methods of quantitative analysis), APIs, medicinal products, bioassay

Lectures

Drug Identification

Detection of drugs using physical constants,  physicochemical methods (spectral, separational methods) and chemical methods

Group and selective reactions of individual structural types of drugs of important pharmacotherapeutic groups (analgesics-antipyretics, analgesics-anodynes, sedatives, anaesthetics, hypnotics, psychopharmaceuticals, analeptics, local anaesthetics, myorelaxants,etc.)

Tests on the purity of drugs (chemical tests chromatographic and spectral methods)

Determination of drug content (Pharmacopoeia Methods of Quantitative Analysis) APIs and Medicinal Products

Stability studies of pharmaceuticals

Development of methods for drug analysis

Chiral analysis

Seminars and Practical training

Analytical evaluation of pharmaceuticals using pharmacopoeia

Identification of the drug using physico-chemical constants, chemical reactions, physicochemical methods

Tests on the purity of drugs (chemical evidence of impurities, evidence of impurities or degradation products by chromatographic and spectral methods)

Determination of drug content (pharmacopoeial methods of quantitative analysis), APIs, medicinal products, bioassay

Last update: Kučera Radim, doc. PharmDr., Ph.D. (02.09.2024)
 
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