Principles and Methods of Pharmaceutical Analysis with Laboratory

A.Y. 2024/2025
6
Max ECTS
72
Overall hours
SSD
CHIM/08
Language
Italian
Learning objectives
The course, which also includes laboratory practicals, allows the student, for the first time in the course of study, to approach the experimental chemistry, and particularly the practice of chemical analysis. Its main purpose is the learning of a correct, accurate and conscious "modus operandi" in the implementation of the elementary methods that this practice entails. To this end, the fundamental principles and methods of qualitative pharmaceutical analysis are illustrated in the lectures and implemented in the subsequent laboratory exercises, with special regard to the identification of inorganic substances of pharmaceutical interest. The student has the opportunity to perform recognition, characterization and compliance procedures with the standards required and prescribed for these substances by the Italian Pharmacopoeia and the European Pharmacopoeia.
Expected learning outcomes
By the end of the course the student will acquire the analytical principles and methods applied to the analysis of inorganic substances of pharmaceutical interest. The student will be able to choose the most suitable method for the analysis of these substances and to apply the basic techniques for their recognition. The student will therefore know how to characterize the chemical composition of an inorganic substance for pharmaceutical use and establish its compliance with the standards required by the Italian Pharmacopoeia and the European Pharmacopoeia. The course will also provide the student with the basic notions of the pharmacological and/or toxicological properties of inorganic substances of pharmaceutical interest.
Single course

This course can be attended as a single course.

Course syllabus and organization

Linea AK

Responsible
Lesson period
First semester
Course syllabus
The teaching program includes presentation and discussion of the following topics: (a) safety regulations in a chemical laboratory; prevention of laboratory hazards; (b) generalities on laboratory operations and equipment; (c) introduction to qualitative inorganic chemical analysis; (d) theoretical aspects of solubilization, extraction and precipitation processes; (e) oxidation-reduction equilibria in relation to pH and precipitation; (f) formation of complexes and their stability as a function of pH; dissolution of precipitates by complexation; (g) cation analysis (classical systematic analysis with subdivision into six analytical groups); (h) anion analysis; (i) guide to the identification of water-soluble inorganic substances from the Pharmacopoeia; (l) guide to the identification of water-insoluble inorganic substances from the Pharmacopoeia; (m) hints on the biochemical, chemico-pharmaceutical, and toxicological implications of inorganic substances under analysis; (n) trace analysis: the limit assays.
Prerequisites for admission
In order to profitably follow the face-to-face lectures in this course, the student must have basic knowledge of general and inorganic chemistry. Admission to attend the laboratory is subject to passing the General and Inorganic Chemistry and Stoichiometry examination.
Teaching methods
Classroom lectures and single-seat laboratory exercises. Classroom attendance is strongly recommended and preparatory to the exercises that will be conducted in the laboratory. Lab attendance is mandatory.
Teaching Resources
The slides used by the professor during the lectures and the procedures for laboratory exercises are comprehensive and are progressively made available to students on UNIMI's Ariel portal.
The following texts are recommended for further study:
- A. Araneo / Chimica Analitica Qualitativa / Casa Editrice Ambrosiana
- F. Savelli, O. Bruno / Analisi Chimico Farmaceutica / Piccin Editore, Padova
- F.P. Treadwell / Chimica Analitica, Analisi Qualitativa / Casa Editrice Vallardi
- G. Svehla / Vogel's Qualitative Inorganic Analysis / John Wiley & Sons, New York
- Farmacopea Ufficiale della Repubblica Italiana
- European Pharmacopoeia
Assessment methods and Criteria
The examination consists of a written test and three practical laboratory tests.
The written test, which lasts 90 minutes, consists of a series of open-ended questions of both theoretical and applied nature with which the student can total up to a maximum of 24 points.
In the practical tests, which allow the remaining 6 points to be totaled, the student is required to recognize inorganic or metallorganic salts (single or in mixtures).
Evaluation of the tests will take into account knowledge of the principles and methods for the qualitative and semi-quantitative analysis of inorganic and metallorganic substances, knowledge of the pharmacological or biomedical properties of inorganic and metallorganic substances listed in the Pharmacopoeia, and the student's ability to apply the main methods of qualitative analysis in order to identify inorganic and metallorganic substances listed in the Pharmacopoeia and to handle related analytical problems independently.
The final grade is expressed in thirtieths (30/30) and will be communicated automatically when the final results are entered with the possibility for the student to reject the grade obtained. The professor is available for review of the exam with students.
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 6
Single bench laboratory practical: 48 hours
Lessons: 24 hours
Shifts:
Professor: Matera Carlo
Turno 1
Professor: Grazioso Giovanni
Turno 2
Professor: Matera Carlo

Linea LZ

Responsible
Lesson period
First semester
Course syllabus
The course focuses on the following topics: (i) safety rules in a chemical laboratory; prevention of laboratory risks; (ii) general information on operations and laboratory equipment; (iii) introduction to inorganic qualitative chemical analysis; (iv) theoretical aspects of solubilization, extraction and precipitation processes; (v) oxidation-reduction equilibria in relation to pH and precipitation; (vi) formation of complexes and their stability as a function of pH. Dissolution of precipitates by complexation; (vii) analysis od cations by classical systematic analysis with subdivision into the six analytical groups; (viii) analysis of anions; (ix) guide to the identification of water-soluble inorganic substances of the EP; (x) guide to the identification of water-insoluble inorganic substances; (xi) biochemical, chemical-pharmaceutical and toxicological properties of the inorganic substances under analysis; (xii) limit tests.
Prerequisites for admission
To successfully follow the lessons of this course, the student must have basic knowledge of general and inorganic chemistry.
Teaching methods
Frontal lessons and individual practical training.
Teaching Resources
The powerpoint presentations used for the lessons are available to students on UniMi's Ariel platform.
For further information, the following texts are recommended:
- A. Araneo, Chimica analitica qualitativa, Casa Editrice Ambrosiana.
- F.P. Treadwell, Chimica Analitica, Analisi qualitativa, Casa Editrice Vallardi.
- G. Svehla, Vogel'sQualitative Inorganic Analysis, John Wiley & Sons, New York.
- G. Charlot, Analisi Chimica qualitativa, Piccin Editore, Padova.
- Farmacopea Ufficiale della Repubblica Italiana X e XI Ed.
- Farmacopea Europea IV Ed.
Assessment methods and Criteria
The exam consists of two tests: practical and written ones. In the practical test, the student has to recognize 4 single inorganic salts and two inorganic salts in a mixture, totaling a maximum of 6/30 points. The written test is based on specific questions (both theoretical and applicative) in which the student can score the remaining 24/30 points.
The evaluation of the test will take into account the student's ability to know how to apply the main methods of qualitative analysis in order to identify inorganic active ingredients reported in the Pharmacopoeia and the ability to independently manage the related analytical problems.
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 6
Single bench laboratory practical: 48 hours
Lessons: 24 hours
Professor(s)
Reception:
Friday 10.30 -12.30, fixing an appointment by email
Office 2015 - Lab. 2053 - Via L. Mangiagalli 25
Reception:
Mon-Fri by appointment
via Luigi Mangiagalli 25, second floor