Catalogo dei Corsi di studio

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, through 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.

Specific expected learning outcomes
1. Knowledge and understanding
The student will know all the aspects related to the recognition of compounds present in the European Pharmacopoeia, the recognition tests and the instrumental essays.
During the frequency of single-seat exercises the student will compare himself with practical experiences aimed at verifying the full comprehension of the topics developed during the lessons in the classroom.

2. Applying knowledge and understanding
At the end of the course the student will have acquired the theoretical and practical knowledge for the recognition of an unknown substance, for purification and determination of purity according to European Pharmacopoeia. The understanding of the topics developed will allow the student to apply the knowledge acquired in the field of quality control (QC).

3. Making judgements
Le lezioni pratiche sono interattive e danno l’opportunità allo studente di sperimentare e realizzare il riconoscimento e la purificazione delle sostanze, nonché a determinarne la purezza secondo Farmacopea Europea. Durante lo svolgimento del corso, attraverso la realizzazione di prove incognite, lo studente viene stimolato alla stesura di relazioni in cui vengono raccolte le esperienze pratiche realizzate, interpretando i dati ottenuti.

4. Communication skills
Lo studente potrà dare evidenza del suo apprendimento durante le esercitazioni pratiche, durante la prova incognita prevista al termine delle esercitazioni e durante la prova orale. Per valutare le abilità comunicative viene stimolato il lavoro in team ed il confronto a piccoli gruppi ed il confronto con esperti del settore farmaceutico.

5. Learning skills
The student will be presented with various consultation tools during the course that will allow him to independently develop a course of study and study of the topics covered.

Programme

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.
In order to attend the laboratory it is mandatory to have a certificate of attendance to a specific training course of information, training and training on safety and health in the workplace.

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: 10 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 - 2 hours

- SAFETY AND HEALTH AT THE WORKPLACE - 8 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

Adopted texts

Irene Briguglio, Antonio Carta, Sandra Piras: Manuale di analisi farmaceutica. Analisi Organica Qualitativa non Strumentale – Aracne Editrice
Carini V., Andrisano V. - Principi di Analisi Farmaceutica - Società editrice Esculapio
F. Chimenti; Identificazione sistematica di composti organici. Ed. Grasso
Lesson slides
Consultation texts:
Farmacopea Ufficiale Italiana
European Pharmacopeia
Merck Index

Bibliography

The teacher will make available to the students on the e-learning page of the course, updated links that will cover the evolution of topics concerning the chemical-physical analysis of drugs.

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.

Frequency modes

The attendance of classroom lectures is not mandatory but strongly recommended. The practical experiments are compulsory.

Exam modes

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.

Exam reservation date start	Exam reservation date end	Exam date
15/10/2021	17/01/2022	24/01/2022
15/10/2021	09/02/2022	14/02/2022
15/10/2021	06/04/2022	11/04/2022
15/10/2021	13/06/2022	20/06/2022
15/10/2021	04/07/2022	11/07/2022
20/09/2022	20/09/2022	27/09/2022
15/10/2021	19/09/2022	29/09/2022
24/10/2022	09/12/2022	13/12/2022
24/10/2022	18/01/2023	23/01/2023