PHARMACEUTICAL AND TOXICOLOGICAL ANALYTICAL CHEMISTRY III

Course objectives

General expected learning outcomes The course of Chemical Pharmaceutical and Toxicological Analysis III aims to provide the theoretical and practical knowledge related to the recognition of compounds of pharmaceutical interest, prevalently with an organic structure, by means of specific chemical assays and instrumental analytical techniques. The student will acquire the ability to understand and apply the methods reported in the latest edition of the European Pharmacopoeia. The course also aims to provide the student with the principles of quality assurance in pharmaceuticals. Specific expected learning outcomes 1. Knowledge and understanding At the end of the course, the student will have in-depth knowledge of aspects related to the recognition and evaluation of the purity of compounds in the European Pharmacopoeia, be able to perform both chemical and instrumental recognition assays. 2. Applying knowledge and understanding At the end of the course the student must be able to recognize an unknown substance using the assays described in the European Pharmacopoeia. It must also be able to purify and determine the purity of the substances present in the European Pharmacopoeia. 3. Making judgements The practical lessons are interactive and give the opportunity to the student to experiment and realize the recognition and purification of substances, and to determine the purity according to European Pharmacopoeia. 4. Communication skills The student will be able to give evidence of his learning during practical exercises, during the unknown test scheduled at the end of the exercises and during the oral exam. 5. Learning skills At the end of the course, the student must be independent in the evaluation of a path of analysis of active ingredients present in pharmaceutical formulations.

Channel 1
PAOLO GUGLIELMI Lecturers' profile

Program - Frequency - Exams

Course program
The course has as its object the identification of drugs, in particular of the organic, metallorganic and inorganic drugs registered in the Official European Pharmacopoeia. PRELIMINARY ASSAYS - 12 hours Organoleptic examination Combustion Assay of Lassaigne: search for N, S, halogens, P, As Assays for aromaticity: Le Rosen, Friedel and Craft Oxidation tests Assay with FeCl3 Assay of Lieben SOLUBILITY TASKS - 4 hours Information deriving from the solubility tests RECOGNITION OF FUNCTIONAL GROUPS - 30 hours Monocarboxylic acids Bicarboxylic acids hydroxy Acids Phenols Polyphenols alcohols Polyhydroxyl compounds or polyalcohols Carbonyl derivatives: Aldehydes Ketones Carbohydrates Esters, lactones, anhydrides Ethers Halogen derivatives amines Diamines aminophenols amides Amino acids Ammonium salts Ureic derivatives and carbamates nitro compounds IDENTIFICATION OF PHARMACEUTICAL STRUCTURES - 12 hours Determination of Chemical-Physical parameters: 12 hours Fusion point Freezing point Boiling point Index of Refraction Thermogravimetry Density Rotary Power - Polarimetry Purification and separation of Active Principles - 12 hours Crystallization Sublimation Distillation Extraction Sample preparation: Extraction methods - 4 hours - SAFETY AND HEALTH AT THE WORKPLACE - 4 hours - Reference legislation - Risk assessment document (DVR) - Definition of risk and danger - Classification of risks - Risks in a chemical laboratory - Risks from chemical agents - Classification of chemical substances - Incompatibility - Occupational Exposure Limits (TLV, TLV-TWA, TLV-STEL, TLV-C, LD50, LC50, NOAEL) - Safety data sheets (SDS) - Regulation R.E.A.CH., CLP and GHS - Personal protective equipment (D.P.I.) and collective protection devices (hoods) - Rules of behavior in a chemical laboratory - Poster design for security
Prerequisites
The prerequisites that are considered necessary for the successful completion of the course concern knowledge of General and Inorganic Chemistry, Organic Chemistry and Analytical Chemistry.
Books
Irene Briguglio, Antonio Carta, Sandra Piras: Manuale di analisi farmaceutica Analisi Organica Qualitativa non Strumentale – Aracne Editrice F. Chimenti; Identificazione sistematica di composti organici. Ed. Grasso Carini V., Andrisano V. - Principi di Analisi Farmaceutica - Società editrice Esculapio Dispense delle lezioni Testi di consultazione: Farmacopea Ufficiale Italiana Farmacopea Europea Merck Index
Teaching mode
This course provides the students with the theoretical knowledge and technical skills for the research and identification of cations and anions from complex chemical mixtures, also deepening toxicological aspects of them. 56 hours lectures will be used to deliver the core material. The practical sessions will complement the material presented in lectures by 60 hours Individual teaching laboratory lectures. It will provide guidance and experience of following written experimental procedures and help students to consolidate their practical skills and the subsequent reporting and analysis of practical results.
Frequency
The attendance of classroom lectures is not mandatory but strongly recommended. The practical experiments are compulsory.
Exam mode
Learning will be assessed by taking a written test and an oral test. Learning during practical exercises will also be considered with specific laboratory experiences.
Lesson mode
The course includes classroom lectures and practical experiments. The attendance of classroom lectures is not mandatory but strongly recommended. The practical experiments are compulsory concerning the identification of substances in the Official Pharmacopoeia, unitary operations of purification and determination of chemical and physical parameters. Classroom lectures, in case of dispositions regarding the evolution of the Covid-19 pandemic, can also be carried out with modalities that will be promptly communicated on the e-learning site of the course.
  • Lesson code1022763
  • Academic year2024/2025
  • CourseIndustrial pharmacy
  • CurriculumSingle curriculum
  • Year4th year
  • Semester1st semester
  • SSDCHIM/08
  • CFU10
  • Subject areaDiscipline Farmaceutico-alimentari