Introduction to Industrial Pharmaceutical Analysis

Course Information
TitleΕισαγωγή στη Βιομηχανική Φαρμακευτική Ανάλυση / Introduction to Industrial Pharmaceutical Analysis
CodeΠΜΣΒΦ-002
FacultyHealth Sciences
SchoolPharmacy
Cycle / Level2nd / Postgraduate
Teaching PeriodWinter
CoordinatorAikaterini Markopoulou
CommonNo
StatusActive
Course ID600016978

Programme of Study: Masrter's Degree in the Industrial Pharmaceutical

Registered students: 11
OrientationAttendance TypeSemesterYearECTS
KORMOSCompulsory Course117.5

Class Information
Academic Year2023 – 2024
Class PeriodWinter
Faculty Instructors
Weekly Hours5
Class ID
600239973
Course Type 2021
Specialization / Direction
Mode of Delivery
  • Face to face
  • Distance learning
Learning Outcomes
After the succesful end of the course, postgraduates will be able to develop an analytical method for the quantification of two or three substances in pharmaceutical formulations. In addition, postgraduates are trained in all the “in process “ analytical methods related to the release of a batch from the production unit to consumption.
General Competences
  • Apply knowledge in practice
  • Retrieve, analyse and synthesise data and information, with the use of necessary technologies
  • Adapt to new situations
  • Make decisions
  • Work autonomously
  • Work in teams
  • Work in an interdisciplinary team
  • Generate new research ideas
  • Design and manage projects
  • Advance free, creative and causative thinking
Course Content (Syllabus)
1. Introduction to analytical concepts: Quality control of analytical methods. Terms used in the control of analytical procedures. Basic calculations in pharmaceutical analysis. 2. Evaluations and statistical processing of detailed results. Pharmacopoeias and their usefulness as appropriate tools for the application of analytical methods. Applications / Examples. Create an internal / external template reference curve 3. Ultraviolet spectrophotometry, in medicinal substances and in medicinal plants. 4. Stability study of active pharmaceutical compounds in different solvents (MeOH, H2O, HCl 0.1N, NaOH 0.1N) and selection of the most suitable for qualitative UV assays. 5. Descriptive statistics, Estimation, Measurement Uncertainty, confidence limits. 6. Raw material control: General principles of atomic emission and absorption spectrometry. Testing of heavy metal impurities in raw materials by atomically emitted plasma emission spectrometry (ICP-AES) 7. “In process” Drug control methods: Dissolution process. Weight uniformity test. Fragmentation time test. Brittleness test. Control of height (thickness) of tablets. Mechanical strength test of tablets. 8. Quantification of an active compound in tablets, with a UV detector. The quantification will be made using external calibration model of one point. 9. Content Uniformity Test 10. Derivative spectra. Development of an analytical “UV derivative ratio“ method for the determination of two or three APIs. 11. General principles of X-rays, X-ray diffraction. Infrared spectrophotometry. 12. FTIR spectra for drug identification. Determination of thermal properties of drugs using Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA).
Educational Material Types
  • Notes
  • Slide presentations
  • Interactive excersises
Use of Information and Communication Technologies
Use of ICT
  • Use of ICT in Course Teaching
  • Use of ICT in Laboratory Teaching
  • Use of ICT in Communication with Students
Course Organization
ActivitiesWorkloadECTSIndividualTeamworkErasmus
Lectures135
Laboratory Work21
Tutorial21
Written assigments20
Exams8
Total205
Student Assessment
Student Assessment methods
  • Written Exam with Multiple Choice Questions (Summative)
  • Written Exam with Short Answer Questions (Summative)
  • Written Exam with Extended Answer Questions (Summative)
  • Written Assignment (Formative)
  • Oral Exams (Formative)
  • Written Exam with Problem Solving (Summative)
  • Labortatory Assignment (Formative)
Bibliography
Additional bibliography for study
Εισαγωγή στη Φαρμακευτική Αναλυτική Χημεία, S. Pedersen-Bjergaard, B. Gammelgard, T. Gronhaug Halvorsen
Last Update
19-01-2024