Study-unit CRUG ANALYSIS II - MOD. I AND MOD. II
| Course name | Pharmacy |
|---|---|
| Study-unit Code | A001742 |
| Location | PERUGIA |
| Curriculum | Comune a tutti i curricula |
| Lecturer | Stefano Sabatini |
| CFU | 12 |
| Course Regulation | Coorte 2022 |
| Supplied | 2025/26 |
| Supplied other course regulation | |
| Type of study-unit | Obbligatorio (Required) |
| Type of learning activities | Attività formativa integrata |
| Partition |
DRUG ANALYSIS II - MOD. I
| Code | A001743 |
|---|---|
| Location | PERUGIA |
| CFU | 5 |
| Lecturer | Giuseppe Manfroni |
| Lecturers |
|
| Hours |
|
| Learning activities | Caratterizzante |
| Area | Discipline chimiche, farmaceutiche e tecnologiche |
| Sector | CHIM/08 |
| Type of study-unit | Obbligatorio (Required) |
| Language of instruction | Italian |
| Contents | A theoretical and practical overview of the main instrumental techniques used to identify and characterise organic molecules, drugs, and healthcare products. |
| Reference texts | V. Cavrini, V. Andrisano. Principi di Analisi Farmaceutica IV Edizione. Esculapio. Testi per la consultazione: Holler, Skoog, Crouch. Chimica Analitica Strumentale II ed. EDISES K.A. Rubinson, J.F. Rubinson. Chimica Analitica Strumentale. Zanichelli |
| Educational objectives | On completing the Analysis of Drugs and Health Products II module, students will have acquired the fundamental concepts of instrumental analysis applied to the assay and dispensing of drugs and products used in healthcare. The course covers the following topics: light-matter interaction; the origin and interpretation of UV, IR and NMR (1H and 13C) spectra; the effect of solvents on instrumental techniques; and basic instrumentation. Polarimetric and refractometric instrumental analyses. Theoretical and practical basis for using X-ray diffraction and electron microscopy techniques in the structural and morphological characterization of drugs in order to understand the physical principles of the techniques, interpret experimental data, and evaluate the information obtained in terms of crystal shape, morphology, and purity. Skills: interpreting simple spectra of organic molecules and choosing appropriate instrumental methods for structure confirmation, assaying and estimating the purity of a given drug sample. During the practical sessions, students will learn to use the essential instrumentation required for instrumental analysis. |
| Prerequisites | Before attending the teaching modules for Drug Analysis II (Module I), students must meet the following prerequisites: It is essential to understand the topics covered in the General and Analytical Chemistry course, and students are expected to be familiar with the fundamental concepts of physics, such as electromagnetism and optics, the corpuscular and wave theories of light, and classical mechanics. Other prerequisites for successfully attending the course relate to organic chemistry, including nomenclature and knowledge of functional groups and their reactivity and reaction mechanisms. |
| Teaching methods | Lectures with video-projected explanatory slides and an opportunity to actively interact with the lecturer by asking questions and offering critical insights. There will be exercises on the interpretation of NMR, IR, UV and XRD spectra. Practical and theoretical exercises will be organised during the semester and before exam sessions as part of integrated teaching. |
| Other information | Practical and theoretical exercises will be organized during the semester and before the exam sessions. These activities are within the supplementary teaching activity. |
| Learning verification modality | The oral exam will be essentially focused on four open questions and will be aimed at verifying that the student is capable of arguing the answer to a particular question in a competent, punctual, clear but synthetic way. The student must demonstrate that it has acquired the skills and abilities required by the course. For the course of Analysis of Medicines III, the oral examination provides that the student is capable of interpreting NMR and IR spectrum of simple organic molecules or drugs. Students with disabilities are invited to visit the following link: http://www.unipg.it/disabilita-e-dsa |
| Extended program | Introduction to the course: teaching method, role and importance of instrumental techniques for the Pharmaceutical Analysis, the European and Italian Pharmacopoeias, monographs of drugs and instrumental analysis herein reported. Light-matter interaction: corpuscolar-ondulatory theory of light, wavelength, frequency and energy, light speed on to materials with different density, absorption, emission, photoluminescence, electromagnetic spectrum and associated instrumental analyses. Refractometric technique: light speed on to materials with different density; definition and meaning of the refractive index; geometric definition, absolute and relative indices of refraction, determination of the limit angle, parameters that affect the refractive index, Abbe refractometer. Polarimetric technique: concept of chirality and asymmetry of molecules, symmetry operations in molecules that do not possess chiral centers, polarized light and Nicol's prism, light-matter interaction (circularly polarized light components on the floor), Fresnel's law, optical specific rotation angle in the Pharmacopoeia, parameters affecting the deflection angle of polarized light, polarimeter. UV spectroscopy: the Beer-Lambert's law and deviations from linearity; the concepts of absorbance and transmittance; the molar absorptivity coefficient; electronic transitions; their significance and energies involved (HOMO-LUMO transitions), concepts of the chromophore and auxochrome; conjugation effect; effect of the solvent, the statistical probability of transition and extension of the chromophore as factors influencing the molar absorptivity coefficient, influence of pH on auxochromes, sample preparation, instrumentation. IR spectroscopy: harmonic and anharmonic oscillators, Hooke's law; the vibrational quantum number; electric dipole moment; general conditions for the absorption of IR radiation; degrees of vibrational modes for linear and no-linear molecules; frequency of stretching and bending of the main bonds; overtones and combination bands; inactive IR absorption; sample preparation and use of solvents; instrumentation and analysis of spectra of simple organic molecules and drugs. Nuclear magnetic resonance spectrometry: Historical milestones of NMR; properties of nuclei with magnetic spin; the concept of magnetic resonance (Larmor frequency and radiation incident on core precession); the effect of a magnetic field on spin populations; the concept of chemical shift and the use of TMS as a reference molecule; spin–spin coupling and coupling constants; magnetic spin multiplicity. First and second order spectra; AM, AX, A2X3 and AA'XX', AA'BB' systems; the use of deuterated water; H-H and H-F coupling constants; the diagnostic significance of coupling constants in determining molecular structure; the magnets employed in NMR; Fourier spectrum acquisition (pulse NMR); instrumentation; and spectra of simple organic molecules and drugs. NMR of carbon-13: general aspects and conditions of 13C resonance, H-C totally coupled spectra and decoupling, methods for recording a 13C spectrum, JMOD spectra and the chemical shifts of carbons in main functional groups and molecular portions, and C-F coupling and coupling constants. Spectra of simple organic molecules and drugs. Amorphous state and crystalline state. Pharmaceutical polymorphism and its importance for bioavailability, stability, and technological properties. Elemental cells, Bravais lattices, Miller indices, crystal symmetries. Crystalline systems relevant to organic molecules. Radiation/matter interaction. Bragg's law. Qualitative analysis and phase identification. Effects of disorder, broad peaks, presence of amorphous. Examples of polymorph identification. Instrumental geometries: Bragg-Brentan. Sampling, sample preparation. Reading and interpretation of a diffractogram of a drug substance. Electron-matter interaction, generation of secondary and backscattered electrons. Morphological analysis of APIs, co-crystals, hydrated forms. Study of surfaces, porosity and particle aggregation. Examples of SEM and TEM analysis. Elemental microanalysis (EDX) as a complementary tool. Presentation of real examples from scientific literature or pharmaceutical industry: identification of a polymorph by XRD; comparison of two formulations with different morphology by SEM. |
| Obiettivi Agenda 2030 per lo sviluppo sostenibile | Development of sustainable methods of drug analysis. Application of green chemistry principles in instrumental analysis techniques. |
DRUG ANALYSIS II - MOD. II
| Code | A001745 |
|---|---|
| Location | PERUGIA |
| CFU | 7 |
| Lecturer | Stefano Sabatini |
| Learning activities | Caratterizzante |
| Area | Discipline chimiche, farmaceutiche e tecnologiche |
| Sector | CHIM/08 |
| Type of study-unit | Obbligatorio (Required) |
Cognomi A-L
| CFU | 7 |
|---|---|
| Lecturer | Stefano Sabatini |
| Lecturers |
|
| Hours |
|
| Language of instruction | Italian |
| Contents | Calcination of organic, organometallic and inorganic drugs. Qualitative research of the following elements: carbon, hydrogen, nitrogen, sulfur, halogens. Solubility. Characterization of the following functional groups: carboxylic acids, alcohols, phenols, ethers, aldehydes and ketones, amines, amides, nitro group, amino acids. Search of the double bond and aromatic structure. Specific assays for recognition of: acetates, citrates, tartrates, lactates, benzoates, salicylates, xanthine derivatives, aminobenzensulpholfonamides and sugars. Practical exercises on the recognition of inorganic, organometallic and organic drugs enrolled in FU XII and EP 11. |
| Reference texts | References: - E. Camaioni - Compendio teorico-pratico di analisi farmaceutica. Riconoscimento delle sostanze solide iscritte nelle vigenti farmacopee - Editrice Bertoni - Handouts given by the teacher; - A. Carta, M. G. Mamolo , F. Novelli, S. Piras - Analisi Farmaceutica Qualitativa - Editrice EDISES Reference texts: - F. Savelli, O. Bruno, Analisi Chimico Farmaceutica, Ed. Piccin - Padova - F. CHIMENTI, Identificazione sistematica di composti organici, Ed. Grasso. - Vogel - Chimica organica pratica - Casa editrice ambrosiana - Italian Pharmacopoeia and XII. European Pharmacopoeia 11th Ed. |
| Educational objectives | Knowledge of basic practical analysis and instrumental techniques to perform a qualitative analysis of a drug. Ability to recognize, to apply techniques and methodologies for the development of a rational path that identifies a substance of pharmaceutical interest. Ability, based on experimental results, to interpret the information obtained and evaluate the results. Ability to use the specific language of this discipline and to present the results obtained and the methodologies used in a report clear, comprehensive and meaningful to completely describe the problem. The student will be guided through a logical pathway that will enable him to identify virtually all compounds of pharmaceutical interest enrolled in F.U. XII and EP 11. |
| Prerequisites | In order to gain access to the course, the student will have to comply with the pre-requisites both general and the frequency and between examinations provided by the current Regolamento Didattico del Corso di Laurea Magistrale in Farmacia (https://dsf.unipg.it/files/clmfarm/2025-26/clm_fa_reg._did._2025-2026.pdf) |
| Teaching methods | The course is organized as follows: - Lectures on all the subjects of the course. - laboratory exercise, chronologically related to lectures, devoted to the learning of the basic analytical practical and instrumental techniques aimed to the execution of the qualitative analysis of compounds of pharmaceutical interest. Students will be divided, according to their number, in groups of about 25. Each of the 10 practical lessons will have a duration of about 4.5 hours for an amount of 45 hours/student. |
| Other information | Mandatory attendance at least at 80% of both practical and theoretical lectures. |
| Learning verification modality | - Final Practice Test in which to the student will be asked to identify two drugs registered in the existing Official Pharmacopoeia (1 organometallic and 1 organic drugs); - Oral examination in which the teacher verifies the student's mastery in resolving issues related to the qualitative analysis of drugs. For information on support services for students with disabilities and/or DSA visit the page https://www.unipg.it/disabilita-e-dsa |
| Extended program | Course overview and outlines about the systematic analysis of pharmaceutical inorganic substances reported in the F.U. XII e EP 11. Characters: physical state, color, and smell. Calcination of inorganic, metal-organic and organic substances with examples of substances that show particular properties (e.g., sublimation). Solubility: definition, expression, factors that influence the solubility: temperature, purity, chemical nature, and structure such as: polarity, hydrogen bond formation, molecular weight variation in a homologous series, melting point, structural isomerism, degree of ionization. Elemental analysis: detection of carbon and hydrogen atoms; Lassaigne test: detection of sulfur, nitrogen, halogens, and phosphorus; Beilstein test. Functional groups analysis: determination of unsaturated C-C bonds and aromatic system, alcohols, phenols, aldehydes and ketones, carboxylic acids and derivatives, amines, amino acids and, nitro derivatives. Systematic analysis of pharmaceutical organo-metallic substances inserted in F.U. XII e EP 11: general scheme and tables. Recognition of organo-metallic and organic salts: acetates, benzoates, salicylates, lactates, gluconates, citrates, and tartrates. Systematic analysis of pharmaceutical organic substances reported in F.U. XII and EP 11: solubility in water, ethyl ether, acids, and bases; solubility classification; neutral, acid, or basic drug properties (general scheme and tables). Analytical profile, recognition reactions and sorting of several classes of pharmaceutical compounds reported in F.U. XII and EP 11: Specific tests for carbohydrates, polyalcohols, sulphonamides, xanthines, amino acids, parabens, saccharin and others. Determination of physico-chemical constants: melting point, specific rotation, and absorbance (1%/1cm). IR Spectra. Chromatography: general aspects and principles of chromatographic separations of complex mixtures, chromatographic parameters, stationary and mobile phases, types of chromatography, diffusion parameters and Van Deemter's law; resolution in chromatography; elution modes. - HPLC: the stationary phases and their size and packing, apparatus needed (pumps, injectors, column, and detectors), normal and reverse phases, eluting methods, UV, fluorescence, and refractive index detectors. |
| Obiettivi Agenda 2030 per lo sviluppo sostenibile | 3, 4, 8 |
Cognomi M-Z
| CFU | 7 |
|---|---|
| Lecturer | Stefano Sabatini |
| Lecturers |
|
| Hours |
|
| Language of instruction | Italian |
| Contents | Calcination of organic, organometallic and inorganic drugs. Qualitative research of the following elements: carbon, hydrogen, nitrogen, sulfur, halogens. Solubility. Characterization of the following functional groups: carboxylic acids, alcohols, phenols, ethers, aldehydes and ketones, amines, amides, nitro group, amino acids. Search of the double bond and aromatic structure. Specific assays for recognition of: acetates, citrates, tartrates, lactates, benzoates, salicylates, xanthine derivatives, aminobenzensulpholfonamides and sugars. Practical exercises on the recognition of inorganic, organometallic and organic drugs enrolled in FU XII and EP 11. |
| Reference texts | References: - E. Camaioni - Compendio teorico-pratico di analisi farmaceutica. Riconoscimento delle sostanze solide iscritte nelle vigenti farmacopee - Editrice Bertoni - Handouts given by the teacher; - A. Carta, M. G. Mamolo , F. Novelli, S. Piras - Analisi Farmaceutica Qualitativa - Editrice EDISES Reference texts: - F. Savelli, O. Bruno, Analisi Chimico Farmaceutica, Ed. Piccin - Padova - F. CHIMENTI, Identificazione sistematica di composti organici, Ed. Grasso. - Vogel - Chimica organica pratica - Casa editrice ambrosiana - Italian Pharmacopoeia and XII. European Pharmacopoeia 11th Ed. |
| Educational objectives | Knowledge of basic practical analysis and instrumental techniques to perform a qualitative analysis of a drug. Ability to recognize, to apply techniques and methodologies for the development of a rational path that identifies a substance of pharmaceutical interest. Ability, based on experimental results, to interpret the information obtained and evaluate the results. Ability to use the specific language of this discipline and to present the results obtained and the methodologies used in a report clear, comprehensive and meaningful to completely describe the problem. The student will be guided through a logical pathway that will enable him to identify virtually all compounds of pharmaceutical interest enrolled in F.U. XII and EP 11. |
| Prerequisites | In order to gain access to the course, the student will have to comply with the pre-requisites both general and the frequency and between examinations provided by the current Regolamento Didattico del Corso di Laurea Magistrale in Farmacia (https://dsf.unipg.it/files/clmfarm/2025-26/clm_fa_reg._did._2025-2026.pdf) |
| Teaching methods | The course is organized as follows: - Lectures on all the subjects of the course. - laboratory exercise, chronologically related to lectures, devoted to the learning of the basic analytical practical and instrumental techniques aimed to the execution of the qualitative analysis of compounds of pharmaceutical interest. Students will be divided, according to their number, in groups of about 25. Each of the 10 practical lessons will have a duration of about 4.5 hours for an amount of 45 hours/student. |
| Other information | Mandatory attendance at least at 80% of both practical and theoretical lectures. |
| Learning verification modality | - Final Practice Test in which to the student will be asked to identify two drugs registered in the existing Official Pharmacopoeia (1 organometallic and 1 organic drugs); - Oral examination in which the teacher verifies the student's mastery in resolving issues related to the qualitative analysis of drugs. For information on support services for students with disabilities and/or DSA visit the page https://www.unipg.it/disabilita-e-dsa |
| Extended program | Course overview and outlines about the systematic analysis of pharmaceutical inorganic substances reported in the F.U. XII e EP 11. Characters: physical state, color, and smell. Calcination of inorganic, metal-organic and organic substances with examples of substances that show particular properties (e.g., sublimation). Solubility: definition, expression, factors that influence the solubility: temperature, purity, chemical nature, and structure such as: polarity, hydrogen bond formation, molecular weight variation in a homologous series, melting point, structural isomerism, degree of ionization. Elemental analysis: detection of carbon and hydrogen atoms; Lassaigne test: detection of sulfur, nitrogen, halogens, and phosphorus; Beilstein test. Functional groups analysis: determination of unsaturated C-C bonds and aromatic system, alcohols, phenols, aldehydes and ketones, carboxylic acids and derivatives, amines, amino acids and, nitro derivatives. Systematic analysis of pharmaceutical organo-metallic substances inserted in F.U. XII e EP 11: general scheme and tables. Recognition of organo-metallic and organic salts: acetates, benzoates, salicylates, lactates, gluconates, citrates, and tartrates. Systematic analysis of pharmaceutical organic substances reported in F.U. XII and EP 11: solubility in water, ethyl ether, acids, and bases; solubility classification; neutral, acid, or basic drug properties (general scheme and tables). Analytical profile, recognition reactions and sorting of several classes of pharmaceutical compounds reported in F.U. XII and EP 11: Specific tests for carbohydrates, polyalcohols, sulphonamides, xanthines, amino acids, parabens, saccharin and others. Determination of physico-chemical constants: melting point, specific rotation, and absorbance (1%/1cm). IR Spectra. Chromatography: general aspects and principles of chromatographic separations of complex mixtures, chromatographic parameters, stationary and mobile phases, types of chromatography, diffusion parameters and Van Deemter's law; resolution in chromatography; elution modes. - HPLC: the stationary phases and their size and packing, apparatus needed (pumps, injectors, column, and detectors), normal and reverse phases, eluting methods, UV, fluorescence, and refractive index detectors. |
| Obiettivi Agenda 2030 per lo sviluppo sostenibile | 3, 4, 8 |