ID:
501324
Duration (hours):
96
CFU:
9
SSD:
CHIMICA FARMACEUTICA
Year:
2025
Overview
Date/time interval
Primo Semestre (29/09/2025 - 23/01/2026)
Syllabus
Course Objectives
The educational objective of the course is to provide students with the basic and specific knowledge of qualitative analysis (identification and quality control of drugs and medicines). The course (which includes individual and group exercises) will give students the ability to plan the most suitable analytical path for the identification of pharmaceutical substances listed in the current Official Pharmacopoeias (with particular reference to the European Pharmacopoeia, EP), even in the context of complex mixtures (e.g., finished pharmaceutical forms, plant matrices). At the end of the course, the expected learning outcomes are:
1) Knowledge of the main functional groups and their physicochemical characteristics
2) Knowledge of the main spectroscopic techniques (IR, NMR, UV-Vis, MS) and separation techniques, both chromatographic (TLC, HPLC) and non-chromatographic (distillation, sublimation, crystallization)
3) Knowledge of conventional and unconventional extraction methods from complex matrices (finished pharmaceutical forms, vegetable matrices)
4) Ability to critically analyze the proposed question and solve it through the theoretical-practical application of points 1,2,3.
1) Knowledge of the main functional groups and their physicochemical characteristics
2) Knowledge of the main spectroscopic techniques (IR, NMR, UV-Vis, MS) and separation techniques, both chromatographic (TLC, HPLC) and non-chromatographic (distillation, sublimation, crystallization)
3) Knowledge of conventional and unconventional extraction methods from complex matrices (finished pharmaceutical forms, vegetable matrices)
4) Ability to critically analyze the proposed question and solve it through the theoretical-practical application of points 1,2,3.
Course Prerequisites
The topics covered during the course require knowledge and skills provided by the following courses: General and Inorganic Chemistry, Anaytical Chemistry, Organic Chemistry 1, Organic Chemistry 2 with elements of spectroscopy.
Particular emphasis will be given to the identification and reactivity of the main functional groups present in organic and organometallic substances, as well as the cations and anions present in inorganic substances.
Particular emphasis will be given to the identification and reactivity of the main functional groups present in organic and organometallic substances, as well as the cations and anions present in inorganic substances.
Teaching Methods
The course includes lectures and practical one-man laboratory and group projects
The frontal lessons (6 CFU), carried out through presentations (PowerPoint) and in-depth analysis (blackboard, material made available on the Kiro platform and on Jove), are constantly integrated with videos and practical notions useful for tackling the laboratory exercises.
When appropriate, the "problem-solving" approach will be adopted, encouraging active participation from the students during the lectures, also with wooclap.
All the educational material is available on the Kiro platform.
For students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Modality, adequate teaching material will be available. If requested, self-learning can be supported by tutoring or supplementary teaching activities, and by dedicated meetings, including online, with time flexibility depending on needs
Laboratory exercises (3 CFU) include single-seat exercises (8 hours) and group exercises (16 hours). The laboratory are mandatory.
During the laboratory, students are called to identify substances of pharmaceutical interest reported in the Official Italian Pharmacopoeia, putting into practice the theoretical notions acquired during the lectures.
In detail, single-seat practical exercises include:
1) Execution of preliminary tests (evaluation of organoleptic characteristics, combustion test, solubility tests) and chemical tests (elemental analysis, analysis of functional groups, specific chemical tests) using known substances, reported in the Official Italian Pharmacopoeia.
2) Plan independently the most suitable analytical path for the identification of 2 unknown substances (powders) reported in the Official Italian Pharmacopoeia.
At the end of the single-seat exercise, the student will have to present a critical commented report.
Group exercises include:
1) TLC on known substances, both pure and in mixtures, reported in the Official Italian Pharmacopoeia.
2) Liquid/liquid extractions, with non-reactive and reactive solvents, on mixtures of known substances, reported in the Official Italian Pharmacopoeia.
3) Separation and identification of substances present in an unknown mixture of substances reported in the Official Italian Pharmacopoeia.
At the end of the group exercise, each group will have to prepare a power point presentation (maximum duration 5') to be displayed in the classroom. Each member of the group must exhibit a part of the carried out work.
To evaluate this part of the laboratory, the teacher will use the moodle platform and, in particular, the workshop (peer evaluation).
To complete the educational offer, 62 hours of support tutoring are provided during the practical laboratory.
The course also includes 4 hours of seminar activities carried out by professionals from the world of the pharmaceutical industry who will provide an insight into the role of analysis in the pharmaceutical sector.
The frontal lessons (6 CFU), carried out through presentations (PowerPoint) and in-depth analysis (blackboard, material made available on the Kiro platform and on Jove), are constantly integrated with videos and practical notions useful for tackling the laboratory exercises.
When appropriate, the "problem-solving" approach will be adopted, encouraging active participation from the students during the lectures, also with wooclap.
All the educational material is available on the Kiro platform.
For students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Modality, adequate teaching material will be available. If requested, self-learning can be supported by tutoring or supplementary teaching activities, and by dedicated meetings, including online, with time flexibility depending on needs
Laboratory exercises (3 CFU) include single-seat exercises (8 hours) and group exercises (16 hours). The laboratory are mandatory.
During the laboratory, students are called to identify substances of pharmaceutical interest reported in the Official Italian Pharmacopoeia, putting into practice the theoretical notions acquired during the lectures.
In detail, single-seat practical exercises include:
1) Execution of preliminary tests (evaluation of organoleptic characteristics, combustion test, solubility tests) and chemical tests (elemental analysis, analysis of functional groups, specific chemical tests) using known substances, reported in the Official Italian Pharmacopoeia.
2) Plan independently the most suitable analytical path for the identification of 2 unknown substances (powders) reported in the Official Italian Pharmacopoeia.
At the end of the single-seat exercise, the student will have to present a critical commented report.
Group exercises include:
1) TLC on known substances, both pure and in mixtures, reported in the Official Italian Pharmacopoeia.
2) Liquid/liquid extractions, with non-reactive and reactive solvents, on mixtures of known substances, reported in the Official Italian Pharmacopoeia.
3) Separation and identification of substances present in an unknown mixture of substances reported in the Official Italian Pharmacopoeia.
At the end of the group exercise, each group will have to prepare a power point presentation (maximum duration 5') to be displayed in the classroom. Each member of the group must exhibit a part of the carried out work.
To evaluate this part of the laboratory, the teacher will use the moodle platform and, in particular, the workshop (peer evaluation).
To complete the educational offer, 62 hours of support tutoring are provided during the practical laboratory.
The course also includes 4 hours of seminar activities carried out by professionals from the world of the pharmaceutical industry who will provide an insight into the role of analysis in the pharmaceutical sector.
Assessment Methods
The acquisition of the credits (9 CFU) is linked to the positive evaluation of the oral test at the end of the course, or on the exam dates, and positive evaluation of the laboratory tests.
The oral examination will start with a barrier question, which consists in writing the general formula of two functional groups. Answering both questions correctly is a mandatory condition to be able to access the oral test.
The oral test will consist of two separate interviews (but contextual as there are two course teachers): one on the identification of biologically active molecules through chemical reactions and/or physical properties; the other on the instrumental methods.
The language skills, both in the oral and in the laboratory tests, contributes to the final assessment.
At the beginning of the course, the teacher will provide a clear and in-depth description of the assessment methods.
The oral examination will start with a barrier question, which consists in writing the general formula of two functional groups. Answering both questions correctly is a mandatory condition to be able to access the oral test.
The oral test will consist of two separate interviews (but contextual as there are two course teachers): one on the identification of biologically active molecules through chemical reactions and/or physical properties; the other on the instrumental methods.
The language skills, both in the oral and in the laboratory tests, contributes to the final assessment.
At the beginning of the course, the teacher will provide a clear and in-depth description of the assessment methods.
Texts
Farmacopea Ufficiale Italiana; Analisi Farmaceutica, David G. Watson, EdiSES; Analisi chimico-farmaceutica, Savelli – Bruno, Ed. Piccin; Analisi farmaceutica metodi di riconoscimento e di separazione, Cavrini V. Andrisano V., Casa Editrice Esculapio. E. G. C. Clarke, “Isolation and identification of drugs”, II Ed., The Pharmaceutical Press, London;
Spectrometric identification of organic compounds, Silverstein, Bassler, Moril, John Wiley and Sons, INC; Analitycal
Profiles of Drug Substances, K. Florey, Academy Press; Analisi Farmaceutica, David G. Watson EdiSES.
Spectrometric identification of organic compounds, Silverstein, Bassler, Moril, John Wiley and Sons, INC; Analitycal
Profiles of Drug Substances, K. Florey, Academy Press; Analisi Farmaceutica, David G. Watson EdiSES.
Contents
In the theoretical part of the course, general analysis methods are covered.
Organoleptic characteristics, solubility tests, and combustion behaviour of substances of pharmaceutical interest.
Organic elemental analysis. Determination of some physicochemical properties (melting point, boiling point, optical rotation).
Study of the main techniques used for the isolation and/or purification of substances of pharmaceutical interest: liquid-liquid extraction, solid-liquid extraction, crystallization, distillation, filtration, centrifugation. Thin layer chromatography (TLC): detection methods (wood lamp, oxidizing and chromogenic reagents), definition of frontal ratio, analytical and preparatory uses. High performance TLC: definition and equipment.
Functional groups: definition and chemical reactivity. Identification reactions of alcohol group, phenolic group, olefinic double bond, carbonyl group, enols, carbohydrates, carboxylic group and derivatives (esters, amides), amines and sulphonamide group.
Analysis and identification of drugs listed in the current Official Pharmacopoeias
Identification of the main cations and anions.
Absorption and emission (fluorescence) spectroscopic techniques: instrumentation and theoretical principles. Adsorption and partition chromatography. Kinetic theory of chromatography, van Deemter equation, HPLC: instrumentation and modules. GC: instrumentation and modules. GC detectors: FID, electron capture detector, thermal conductivity detector, mass detector.
HPLC hyphenation with UV-Vis detector and diode array detector: principles and applications in the pharmaceutical field. HPLC-MS hyphenation: ionization techniques and mass analyzers.
Furthermore, practical laboratory are planned which have a dual objective: the acquisition of practical skills and the development of logical-deductive abilities.
The practical laboratory consists of individual practice aimed at determining the nature of the substance (inorganic, organometallic, organic) and carrying out identification reactions for some classes of compounds of pharmaceutical interest.
In addition, there will be group exercises related to the identification of active principles in mixtures, finished pharmaceutical forms, and complex matrices, using non-chromatographic separation and purification methods, as well as analytical control (TLC).
The identity of the isolated active principles will be confirmed through chromatographic analysis (TLC) using reference standards. IR, UV, NMR, MS spectra may be provided to students to confirm identification.
Organoleptic characteristics, solubility tests, and combustion behaviour of substances of pharmaceutical interest.
Organic elemental analysis. Determination of some physicochemical properties (melting point, boiling point, optical rotation).
Study of the main techniques used for the isolation and/or purification of substances of pharmaceutical interest: liquid-liquid extraction, solid-liquid extraction, crystallization, distillation, filtration, centrifugation. Thin layer chromatography (TLC): detection methods (wood lamp, oxidizing and chromogenic reagents), definition of frontal ratio, analytical and preparatory uses. High performance TLC: definition and equipment.
Functional groups: definition and chemical reactivity. Identification reactions of alcohol group, phenolic group, olefinic double bond, carbonyl group, enols, carbohydrates, carboxylic group and derivatives (esters, amides), amines and sulphonamide group.
Analysis and identification of drugs listed in the current Official Pharmacopoeias
Identification of the main cations and anions.
Absorption and emission (fluorescence) spectroscopic techniques: instrumentation and theoretical principles. Adsorption and partition chromatography. Kinetic theory of chromatography, van Deemter equation, HPLC: instrumentation and modules. GC: instrumentation and modules. GC detectors: FID, electron capture detector, thermal conductivity detector, mass detector.
HPLC hyphenation with UV-Vis detector and diode array detector: principles and applications in the pharmaceutical field. HPLC-MS hyphenation: ionization techniques and mass analyzers.
Furthermore, practical laboratory are planned which have a dual objective: the acquisition of practical skills and the development of logical-deductive abilities.
The practical laboratory consists of individual practice aimed at determining the nature of the substance (inorganic, organometallic, organic) and carrying out identification reactions for some classes of compounds of pharmaceutical interest.
In addition, there will be group exercises related to the identification of active principles in mixtures, finished pharmaceutical forms, and complex matrices, using non-chromatographic separation and purification methods, as well as analytical control (TLC).
The identity of the isolated active principles will be confirmed through chromatographic analysis (TLC) using reference standards. IR, UV, NMR, MS spectra may be provided to students to confirm identification.
Course Language
Italian
More information
All tests will be ORAL and "IN PRESENCE", except for any unexpected issues.
The teacher is available in her office by appointment by email.
To attend the laboratories, students must present the certificate of participation in the course of Specific training (online) on Safety and Health in the Workplace.
The teacher is available in her office by appointment by email.
To attend the laboratories, students must present the certificate of participation in the course of Specific training (online) on Safety and Health in the Workplace.
Degrees
Degrees
MEDICINAL CHEMISTRY AND PHARMACEUTICAL TECHNOLOGY
Single-cycle Master’s Degree
5 years
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People
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