| Module designation | SEDCP616 Validation Of Instrumental Analysis Methods |
| Semester(s) in which the module is taught | 5th Semester and 7th Semester |
| Person responsible for the module | Dr. Ibnu Khaldun, M.Si |
| Language | Indonesian, English (for lecture material) |
| Relation to curriculum | Elective Course |
| Teaching methods | Lecture, small group discussion, case methods, |
| Workload (incl. contact hours, self-study hours) | 2 x 45 hours per semester, comprising: 100 minutes lecture and discussion per week120 minutes structured tasks per week120 minutes learn to be independent per week |
| Credit points | 2 SKS = 3.34 ECTS |
| Required and recommended prerequisites for joining the module | – |
| Module objectives/intended learning outcomes | Students are able to explain the basic principles and importance of method validation in instrumental analysis within laboratory and industrial settings.Students can identify and calculate validation parameters such as accuracy, precision, linearity, LOD, and LOQ.Students are able to design and perform method validation procedures for various analytical techniques such as spectroscopy and chromatography.Students can apply statistical analysis to evaluate the results of method validation.Students are able to prepare validation documentation and reports in accordance with national and international regulatory standards. |
| Content | The Validation of Instrumental Analysis Methods course covers the concepts, principles, and applications of validating analytical methods based on instrumental techniques used in chemical laboratories, industry, and quality control. Topics include understanding key validation parameters such as accuracy, precision, linearity, limit of detection (LOD), limit of quantitation (LOQ), selectivity, and method robustness. Students will explore the validation process across various instrumental techniques such as spectrophotometry, chromatography, and mass spectrometry. In addition to technical aspects, the course equips students with the skills to prepare validation documentation in compliance with national and international regulatory standards, including ISO/IEC 17025 and ICH Guidelines. Practical sessions and case studies are essential components for developing hands-on experience in designing and evaluating validated analytical methods.. |
| Exams and assessment formats | written examinations, case studies, student presentations, and guided class discussions |
| Study and examination requirements | Case methods: 50,3%Quiz: 8,5%Midterm: 8,25%Participatory Activities (Attitude, Discussion, and Presentation): 16,5%Final exam: 16,5% |
| Recommended literature | Skoog, D. A., Holler, F. J., & Crouch, S. R. (2017). Principles of instrumental analysis (7th ed.). Cengage Learning. Miller, J. N., & Miller, J. C. (2018). Statistics and chemometrics for analytical chemistry (7th ed.). Pearson Education. International Conference on Harmonisation. (2005). ICH Q2(R1): Validation of analytical procedures: Text and methodology. ICH Harmonised Tripartite Guideline.Harris, D. C. (2020). Quantitative chemical analysis (10th ed.). W. H. Freeman.EURACHEM. (2014). The fitness for purpose of analytical methods: A laboratory guide to method validation and related topics (2nd ed.). EURACHEM.Snyder, L. R., Kirkland, J. J., & Dolan, J. W. (2011). Introduction to modern liquid chromatography (3rd ed.). Wiley.Taylor, J. K. (1987). Quality assurance of chemical measurements. Lewis Publishers. |
| Date of last amendment | August 12, 2024 |
