FARM2130 – Pharmaceutical Analytical Chemistry
Course description
Schedule, syllabus and examination date
Course content
The course provides a comprehensive introduction to analytical chemistry relevant for chemical quality control of pharmaceutical raw materials and final drug products, and for determination of drugs, metabolites and substances of abuse in biological samples. As the quality of the analytical result is extremely important for the patient safety current regulations and official guidelines from among others The European Pharmacopeia and European Medicines Agency will be central for the teaching.
Learning outcome
After completing the course you will be able to:
- use The European Pharmacopeia and other relevant legislations, regulations and guidelines in the planning and execution of chemical analysis of pharmaceutical raw materials and final drug products.
- account for and explain the most common analytical chemical techniques and methods used in pharmaceutical chemical analysis and bioanalysis, and use this knowledge to discuss and justify the choice of analytical method. This includes both simpler pharmacopeial tests such as melting point, precipitation reactions, optical rotation, and titration, as well as instrumental analytical techniques such as spectroscopy (UV, IR, AAS, and MS) and chromatography (HPLC, GC, and TLC).
- identify the chromatographic principle and associated detection method used in an analysis and discuss why this principle was chosen.
- account for the most important biological matrices and discuss the main sample preparation methods for chemical analysis of pharmaceutical preparations and bioanalysis of drugs, drug metabolites, substances of abuse and doping agents.
- plan and execute qualitative and quantitative analyses of pharmaceutical raw materials and final drug products according to current regulations and evaluate the results of the analyses.
- plan and carry out simple chromatographic analyses for the identification and quantitative determination of drugs in biological samples and evaluate the results of the analyses.
- explain the purpose of method validation and the implementation of system tests, and describe the main method validation and system test parameters.
- perform simple statistical tests for the evaluation of analytical results, and use relevant IT tools for the calculation and presentation of results from quantitative analyses.
Admission to the course
The course is only available to students enrolled at the Deparment of Pharmacy at the University of Oslo.
Pregnant and breastfeeding: This course uses chemicals in laboratory exercises that can be harmful to pregnant and breastfeeding women (fetus/child). No exemption from the laboratory exercises is granted as these must be approved to fulfill the learning outcomes in the course. Students can apply for facilitation; see Special needs and leave of absence. For more information, contact the study administration at the Department of Pharmacy.
Formal prerequisite knowledge
Passed the exam in:
- FARM1100 – Pharmaceutical Chemistry?
- FARM1110 – Pharmacology, Physiology and Cell Biology 1?
- FARM1120 – Social Pharmacy?
- FARM1130 – Pharmaceutically Based Organic Chemistry?
- FARM1140 – Pharmacology, Physiology and Cell Biology 2?
- FARM1150 – Pharmaceutical Based Biochemistry?
- The compulsory HSE courses HMS0501 – Safety and Physical Environment, HMS0502 – Positive Learning Environment, HMS0503 – Laboratory Safety, HMS0506 – Patient Clinic Safety?and HMS0507 – Fire Safety required for students at the 5-year Master`s Programme in Pharmacy.
Approved the compulsory parts of:
Course exemption: Laws and regulations describing the overall learning outcome regulate the Pharmacy Programme. Exemptions are only granted if all learning outcomes in the course are covered.?
Recommended previous knowledge
FARM2100 – Medicinal Chemistry
Overlapping courses
- 6 credits overlap with FRM2010 – Quality Control of Pharmaceutical ingredients (discontinued).
- 5 credits overlap with FARM2135 – OE i legemiddelananlyse.
- 4 credits overlap with FRM3030 – Use of Drugs, Part III (discontinued).
- 4 credits overlap with FARM3190 – OE i fysiologi, farmakoterapi, legemiddelanalyse og farmakognosi (discontinued).
Teaching
The teaching will be given as lectures, student-activating teaching (e.g. flipped classroom, Kahoot/Menti), seminars and laboratory course.
- 30 hours of lectures
- 5 hours of flipped classroom
- 35 hours of laboratory work with subsequent written laboratory reports?- compulsory
- 24 hours of seminars
Compulsory participation in laboratory work and laboratory reports in the course must be completed and approved before sitting the exam.
Read more about what applies in the event of absence from compulsory activities.
As?the?teaching involves laboratory and/or field work, you should consider taking out a separate travel and personal risk insurance. Read about your insurance cover as a student.
A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.
Completed and approved compulsory instruction and coursework are valid for 3 years.
Examination
Final oral exam with 30 minutes preparation time and 30 minutes exam. Oral exam counts?100?% towards the finale grade.?
For admission to the exam you will have to have:
- performed all laboratory exercises
- all laboratory reports approved
Examination support material
You will have access to a calculator during the preparation time of?the exam.
Language of examination
The examination text is given in Norwegian. You may submit your response in Norwegian, Swedish or Danish.
Grading scale
Grades are awarded on a scale from A to F, where A is the best grade and F?is a fail. Read more about the grading system.
Resit an examination
This course offers both postponed and resit of examination. Read more:
More about examinations at UiO
- Use of sources and citations
- Special exam arrangements due to individual needs
- Withdrawal from an exam
- Illness at exams / postponed exams
- Explanation of grades and appeals
- Resitting an exam
- Cheating/attempted cheating
You will find further guides and resources at the web page on examinations at UiO.