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Course, academic year 2022/2023
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Pharmaceutical Analysis II - GF186
Title: Kontrola chemických léčiv II
Guaranteed by: Department of Pharmaceutical Chemistry and Pharmaceutical Analysis (16-16190)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2018
Semester: winter
Points: 0
E-Credits: 5
Examination process: winter s.:oral
Hours per week, examination: winter s.:28/42, C+Ex [HS]
Capacity: unknown / unknown (unknown)
Min. number of students: unlimited
Virtual mobility / capacity: no
Key competences:  
State of the course: not taught
Language: Czech
Teaching methods: full-time
Teaching methods: full-time
Explanation: (F, 4.roč.)
Note: deregister from the exam date if a requisite was not fulfilled
course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: prof. RNDr. Jiří Klimeš, CSc.
doc. PharmDr. Radim Kučera, Ph.D.
doc. PharmDr. Petra Štěrbová, Ph.D.
Classification: Pharmacy > Special Core Subjects
Co-requisite : GF050, GF133, GF141
Pre-requisite : GF156
Is co-requisite for: GF188
Is interchangeable with: GF306
Examination dates   Schedule   
Annotation -
Last update: Ladislava Novotná (19.06.2008)
Drug control is one of the fundamental pharmaceutical disciplines. Theoretical and practical instruction aims to guarantee the quality, safety, and efficiency of drugs, which fulfils an irreplaceable principal function of a course in pharmacy. Instruction includes not only the present editions of the Czech and European Pharmacopoeias but it is also based on other modern pharmacopoeia monographs, mainly the USP (United States Pharmacopoeia). The structure of the drug is the starting point for the determination of a suitable method for the quantitative analysis.
Literature -
Last update: Ladislava Novotná (19.06.2008)

Klimeš J a kol.: Kontrola léčiv I. Praha, Karolinum 2006

Klimeš J a kol.: Kontrola léčiv II. Praha, Karolinum 2007

Český lékopis (poslední platné vydání), Praha, Grada

Roth H. J. a kol.: Pharmaceutical Chemistry, Drug Analysis. Ellis Hordwood, 1991

Syllabus -
Last update: Ladislava Novotná (19.06.2008)


Structure of the drug as the starting point for the determination of analytically usable physicochemical properties

Drug Assay

? Volumetric methods used in pharmacopoeial drug control

? Acid-base titrations of drugs (acidimetry, alkalimetry in aqueous and nonaqueous media)

? Oxidoreduction titrations of drugs (iodometry, bromatometry, manganometry, cerimetry)

? Complexometric titrations of drugs (chelatometry, mercurimetry)

? Determination of drugs by means of precipitation titrations

? Spectrophotometric determination of drugs

? Polarimetric determination of drugs

? Determination of drugs with the use of electroanalytical methods

? Determination of drugs by chromatographic and electrophoretic methods

Purity and stability of drugs

? Pharmacopoeial detection of impurities with the use of chemical reactions by means of physicochemical methods

? Stability of drugs, processes of decomposition, factors influencing stability

? Accelerated stability tests, calculation of kinetic characteristics of decomposition reactions

? Knowledge of chemism of decomposition reactions as the prerequisite of stabilizing interventions

The fundamentals of drug level monitoring

The principles of good laboratory practice


Practical Training

? Test for purity of drugs (chemical detection of impurities, detection of impurities, or degradation products by chromatographic and spectral methods)

? Determination of drug content (pharmacopoeial methods of quantitative evaluation of drugs)

? Control-analytical evaluation of pharmaceutical preparations

? Control of extemporaneously prepared pharmaceutical preparations according to the pharamacopoeia and control-analytical procedures used in drug control laboratories

? Control of mass-produced pharmaceutical preparations according to factory standards (control- analytical methods used in outlet control in pharmaceutical industry)

? Semidemonstrative tasks (use of UV spectrometry in drug control, use of IR spectrometry in drug control, analysis of drugs on the basis of specific optical rotation, analysis of drugs by means of HPLC, monitoring of drugs and metabolites in blood plasma by means of HPLC and TLC)

Teaching methods -
Last update: Ladislava Novotná (19.06.2008)

Lectures, tutorials, practical classes.

Requirements to the exam -
Last update: Ladislava Novotná (19.06.2008)

Credit, exam.

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