| Language of Instruction |
Türkçe |
| Course Type |
Elective Courses |
| Course Instructor(s) |
DR. ÖĞR. ÜYESİ SERKAN LEVENT |
| Mode of Delivery |
Face to face |
| Prerequisites |
There are no prerequisites for this course. |
| Courses Recomended |
None |
| Recommended Reading List |
ICH Q3A (R2), ICH Q3B (R2), ICH Q3C (R8), ICH Q6A Guidelines. David G. Watson, Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists, 2016, Elsevier. Ahuja, S. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, 2003, Academic Press. |
| Assessment methods and criteria |
1 Midterm exam, 1 Final exam. |
| Work Placement |
- |
| Catalog Content |
Introduction and Basic Concepts: Importance of impurities in pharmaceuticals; contaminants,degradation products, residual solvents; Classification of Impurities: Organic impurities, inorganicimpurities, residual solvents (ICH Q3C), degradation products; Sources of Impurities: Process-relatedimpurities (synthesis and manufacturing); storage and packaging effects; excipient-derivedimpurities; environmental contamination; Impurity Limit Values and Regulatory Frameworks: ICHQ3A, Q3B, Q3C guidelines; limit tests; current regulations and pharmacopeial thresholds; Selectionof Analytical Methods and Validation Requirements: Analytical method selection (selectivity,sen |
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