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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.
Last update: Novotná Ladislava (19.06.2008)
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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 Last update: Novotná Ladislava (19.06.2008)
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Lectures, tutorials, practical classes. Last update: Novotná Ladislava (19.06.2008)
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Credit, exam. Last update: Novotná Ladislava (19.06.2008)
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Lectures 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) Last update: Novotná Ladislava (19.06.2008)
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