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Course, academic year 2023/2024
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Pharmaceutical Analysis I - GAF302
Title: Pharmaceutical Analysis I
Guaranteed by: Department of Pharmaceutical Chemistry and Pharmaceutical Analysis (16-16190)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2021
Semester: summer
Points: 0
E-Credits: 3
Examination process: summer s.:
Hours per week, examination: summer s.:28/42, C [HS]
Capacity: unlimited / unlimited (unknown)
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: taught
Language: English
Teaching methods: full-time
Teaching methods: full-time
Note: deregister from the credit exam date if a requisite was not fulfilled
course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: doc. PharmDr. Petra Štěrbová, Ph.D.
Comes under: 2.ročník 2023/24 AJ
Co-requisite : GAF300, GAF301
Interchangeability : GAF156, GAF295
Is pre-requisite for: GAF306
Annotation -
Last update: doc. PharmDr. Petra Štěrbová, Ph.D. (10.02.2022)
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.
Course completion requirements -
Last update: doc. PharmDr. Petra Štěrbová, Ph.D. (10.02.2022)

Credit Requirements

  • Presence at all practical trainings

  • knowledge of discussed topics, Pharmacopoeia knowledge

  • Approved reports from all practical tasks

  • pass of all tests including credit test

Literature -
Last update: doc. PharmDr. Petra Štěrbová, Ph.D. (10.02.2022)



  • EDQM. European Pharmacopoeia 9.0-9.5. null: EDQM, 2017, s. ISBN 9789287183330.
  • Hansen, Steen Pedersen-Bjergaard, Stig Rasmussen, Knut. Introduction to pharmaceutical chemical analysis. Chichester: Wiley, 2012, 494 s. ISBN 978-0-470-66122-2.


  • Ahuja, S., Scypinski, S.. Handbook of modern pharmaceutical analysis. London: Academic Press, 2011, 598 s. ISBN 9780123759818.

Syllabus -
Last update: doc. PharmDr. Petra Štěrbová, Ph.D. (08.08.2022)


  • 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
Teaching methods -
Last update: doc. PharmDr. Petra Štěrbová, Ph.D. (10.02.2022)

Lectures, seminars, practical training

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