General provisions

Substitutes the earlier course 3FK075 or 3FK307, Product and Process Analytical Chemistry.

Entry requirements

150 credits from term 1-5 within the pharmacy programme and participation in earlier courses within the programme. For admission to single subject course is required 150 credits including analytical pharmaceutical chemistry 7.5 credits and bioanalytical chemistry 7.5 credits in the pharmacy programme, or the equivalent in a Bachelor's programme with the combination chemistry/biology in a related study programme, or the equivalent within medicine, biomedicine or veterinary medicine. Knowledge in Swedish and English equivalent to that required for basic qualification to Swedish higher education on basic level.

Learning outcomes

On completion of the course, the student should be able to - account for principles possibilities and limitations for the most common analytical techniques applicable for product analysis - plan for studies of quantitative analyses, purity and stability of pharmaceutical substances and preparations and suggest appropriate analytical methods for respective purposes - describe the principles of quality assurance and GMP considering analytical methods - account for principles possibilities and limitations for the most common analytical techniques applicable for process analysis - describe the different principles that can be used for connection of analytical techniques to processes and state their possibilities and limitations - seek information about application areas within product - or process analysis; and on basis thereof evaluate the described analytical techniques and methods - write a review of an application area in English that follows instructions given in a scientific journal - present, with a PowerPoint presentation or equivalent, and, in a seminar, defend the written review

Content

The course intends to provide knowledge and understanding about analytical chemical techniques and methods with applications within product and process analysis at drug productions. In the course, deeper studies of separation methods are included (liquid chromatography, gas chromatography and capillary electrophoresis), flow-analytical systems, mass spectroscopy, vibration spectrometry, diode array detection, sensors, automation ("high throughput analysis"), introduction to chemometrics, method construction, method validation and work according to GLP. The knowledge shall be possible to be used to develop and assess analytical methods for products of synthesis, drugs, excipients, impurities and degradation products at product and process analysis. Acquired knowledge is applied through literature search resulting in a written and oral presentation of a SHORT ESSAY within an assigned limited field of product and process analysis.

Instruction

The teaching is given as lectures, seminars and group exercises for planning, writing and presentation of a SHORT ESSAY. Special importance is paid to stimulate the students to independently search information and solve problems. Compulsory parts of the course: Course introduction and all the parts in connection with SHORT ESSAYS including group meetings and presentation. Possibility to supplement a failed SHORT ESSAY can be given at the earliest at next course and only in case of a vacancy.

Assessment

Written examination (examination code), SHORT ESSAY in forms of written and oral presentations (examination code).

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.

Each student has the right to in all six examinations i.e. one examination and five re-examinations.