Unit ANALYSIS OF MEDICINAL PRODUCTS AND HEALTH PRODUCTS I

ANALYSIS OF MEDICINAL PRODUCTS AND HEALTH PRODUCTS I - MODULE I

Code	A003562
CFU	6
Teacher	Andrea Carotti
Teachers	Andrea Carotti
Hours	69 ore - Andrea Carotti
Learning activities	Caratterizzante
Area	Discipline farmaceutico-alimentari
Sector	CHIM/08
Type of study-unit	Obbligatorio (Required)
Language of instruction	ITALIAN
Contents	Basic analytical technique and procedures. Official analytical methods. Chemical pharmacotoxicological properties and analytical reactions of inorganic anions and cations listed in the Italian Ph and EurPh.
Reference texts	Lessons Notes - Reading of the European Pharmacopoeia
Educational objectives	At the end of the course we expect that the student will has: a) acquired the best to behave in a chemistry laboratory ; b) learned to observe and interpretate the behavior of the studied compounds ; c) learned to identify an inorganic compound using the most appropriate analytical method; d) learned to build a relationship; and finally e) understand and interpretate the Pharmacopea text. The practical skills acquired during this first laboratory will be indispensible to attend the successive practical courses.
Prerequisites	To access to the laboratory of Analyses of Drugs 1, the student must have attended a safety course in the workplace. Solid knowledge of the general and inorganic chemistry are indispensable. In fact this is a course of purely practical nature which entails the execution of reactions already addressed theoretically during the courses of inorganic analytical chemistry and general chemistry. Prerequisites: passed the examination of inorganic analytical chemistry and general chemistry.
Teaching methods	Face-to-face or remote lessons and Practical training.
Other information	The starting and ending data of the course can be found in the website of the Department http://www.dsf.unipg.it/ - Lectures will be held at , Department of Pharmaceutical Sciences (Via del Liceo, 1) while practical lessons at the Laboratory, Via del Liceo
Learning verification modality	All the laboratory exercises with detection of an unknown substance from Farmacopae will be evaluated. There will also be a final practical exame of laboratory with two unknown substances to be identified. Followed by an oral examination which can only be supported by those students who have passed at least 2/3 of the practical tests.
Extended program	First aid in chemical laboratory. Illustration of laboratory equipment. Basic analytical technique and procedures. Official analytical methods. Chemical pharmacotoxicological properties and analytical reactions of inorganic anions and cations listed in the Italian Ph and EurPh. Identification of compounds in mixtures
Obiettivi Agenda 2030 per lo sviluppo sostenibile

ANALYSIS OF MEDICINAL PRODUCTS AND HEALTH PRODUCTS I - MODULE II

Code	A003563
CFU	6
Teacher	Bruno Cerra
Teachers	Bruno Cerra
Hours	69 ore - Bruno Cerra
Learning activities	Caratterizzante
Area	Discipline farmaceutico-alimentari
Sector	CHIM/08
Type of study-unit	Obbligatorio (Required)
Language of instruction	English
Contents	The course covers the principles and applications of quantitative analytical methods, with particular reference to the assay, according to the Pharmacopeia, of active pharmaceutical ingredients (APIs), either as raw materials or within finished pharmaceutical formulations (tablets, solutions, pastes, granules), using: - Volumetric methods: acid–base titrations (including non-aqueous titrations), precipitation titrations (argentometry), complexometric titrations (EDTA), and redox titrations. - Instrumental methods: UV–Vis spectrophotometry, potentiometry, and HPLC (application in the quantitative analysis of drugs).
Reference texts	- Lecture notes/slides - Italian Official Pharmacopoeia, 12th Edition - European Pharmacopoeia - G.C. Porretta, Analysis of Pharmaceutical Preparations, C.I.S.U. - D.A. Skoog et al., Fundamentals of Analytical Chemistry, EdiSES - ICH Guidelines Q2(R2) – Validation of Analytical Procedures
Educational objectives	By the end of the course, students will have acquired: Knowledge and Understanding of: - Theoretical principles of volumetric titration methods - Fundamentals of instrumental analytical techniques (UV–Vis spectrophotometry, HPLC) - Key validation parameters of analytical methods Skills to: - Perform acid–base, redox, complexometric, and precipitation titrations - Prepare and standardize solutions - Apply spectrophotometric methods and interpret basic chromatographic data - Process analytical data and evaluate its quality Competences for: - Select appropriate analytical methods for pharmaceutical quality control - Apply pharmacopoeial procedures - Evaluate accuracy, precision, and reliability of analytical results - Operate in compliance with quality assurance principles (GLP – Good Laboratory Practice)
Prerequisites	Propedeuticity: General chemistry, Inorganic chemistry
Teaching methods	The course is structured as follows: - Lectures covering theoretical principles and practical applications (24 hours) - Laboratory activity consisting of 10 laboratory sessions (approximately 4 hours each, students are organized into groups, maximum 32 students eahc), including: use of volumetric glassware, preparation and standardization of solutions, application of pharmacopoeial methods, volumetric and spectrophotometric analyses, automated titrations, statistical treatment of analytical data, preparation of technical reports - Team working/problem solving teaching lessons
Other information	Obligatory attendance Location: Dipartimento di Scienze Farmaceutiche, Sezione di Chimica e Tecnologia del Farmaco, Via del Liceo, 1 06123 - Perugia
Learning verification modality	- Laboratory reports (assessment of accuracy, data processing, interpretation, and laboratory report writing) - Oral examination (theoretical knowledge and practical applications) The final grade is based on the evaluation of: theoretical knowledge, practical skills, and the quality of experimental work. For information on support services for students with disabilities and/or specific learning disorders (DSA), please visit: http://www.unipg.it/disabilita-e-dsa
Extended program	Theoretical part Fundamentals of analytical chemistry: analytical process; errors (systematic and random); accuracy and precision; basic statistics; significant figures. Solutions: standard solutions and primary standards; standardization procedures Acid–base titrations: titration curves; indicators; non-aqueous solvents; leveling and differentiating effects Precipitation titrations: argentometry; indicators and titration curves Complexometric titrations: EDTA; effect of pH; methods (direct and indirect); metallochromic indicators Redox titrations: standard potentials; Nernst equation; permanganometry, iodometry, iodimetry, cerimetry, dichromate titrations, bromometry, bromatometry Instrumental methods: potentiometry; UV–Vis spectrophotometry; HPLC (applications for the quantification of active pharmaceutical ingredients) Validation of analytical methods: accuracy; precision (repeatability, reproducibility); specificity; linearity and range; limit of detection (LOD) and limit of quantification (LOQ); robustness Quality assurance: introduction to quality control in the pharmaceutical industry and principles of Good Laboratory Practice (GLP) Experimental part Quantitative analysis of pharmaceuticals (solid and liquid dosage forms) Application of pharmacopoeial methods Volumetric titrations Automated titrations Spectrophotometric analysis Statistical treatment of analytical data Preparation of laboratory reports
Obiettivi Agenda 2030 per lo sviluppo sostenibile