Industrial pharmacy REPLICA LATINA

General Part The Official Pharmacopoeia, Classification of analytical methods: qualitative and quantitative. Analysis of a pharmaceutical preparation: sampling, choice of analytical method, evaluation of results obtained. Instrumentation required in quantitative analysis: calibrated and graduated glassware, analytical and technical balance. Characteristics of the balance, weighing operations; Concepts of mathematics/statistics: Definition of: mean, median, precision and accuracy. Determined and indeterminate errors. Determined errors: effect detection and correction. Indeterminate errors: statistical treatment. Properties of the normal error curve, mean deviation, standard deviation. outlier deviation. A) Volumetric analysis General: Types of reactions used in volumetric analysis; equivalent point; titration curves: strong acid-strong base; weak acid-strong base; polyprotic acid-strong base; construction of a titration curve; ways of expressing concentrations; pH calculation; buffer solutions; acid-base indicators. Acidimetry: the mother substances; preparation and standardisation of an HCl solution, choice of indicator. Applications: sodium carbonate determination, alkaline mixtures; determination of ammoniacal nitrogen: distillation method; ephedrine determination. Alkalimetry: the mother substances; preparation and standardisation of a sodium hydroxide solution. Applications: acetyl salicylic acid determination; boric acid determination; phosphoric acid determination; citric acid determination; phosphoric acid determination; borax determination; chloral hydrate determination; Titration with precipitate formation: NaCl/AgNO3 titration curve; Mohr, Vohlard, Fajans method. Colloids. Applications: preparation and standardisation of a solution of AgNO3; preparation and standardisation of a solution of NH4CNS (KCNS). Analyses: Cyclophosphamide; Chlorbutanol; Chloral hydrate; Mercuric iodide; Mercury; Mercury yellow oxide; Chlorinated potassium; Complexometry and chelometry: generalities; Chelometry: EDTA, α and β factors; End point determination: instrumental method, metal chromic indicators. Chelometric titrations: direct, inverse, displacement method. Applications: preparation and standardisation of an EDTA solution. Aluminium determination; calcium determination; magnesium determination; mercury determination; zinc determination; water hardness determination. Redox titrations: generalities, electrode potential, formal potential. Redox indicators: general, specific. Cerimetry: preparation and standardisation of a cerium solution; menadione, paracetamol, nifedipine analysis. Permanganometry: preparation and standardisation of a permanganate solution; mother substances; determination of calcium, iron, hydrogen peroxide. Iodimetry and iodometry: generalities; influence of pH on equilibria; preparation and standardisation of an iodine solution; preparation and standardisation of a thiosulphate solution; indicators; iodimetry applications: ascorbic acid determination; carbasone determination; captopril determination; mercurous chloride determination; sodium thiosulphate determination. Iodometry applications: active chlorine determination in hypochlorites; hydrogen peroxide determination; chloramine determination; Bromometry: phenol determination; isoniazid determination; sobrerol determination. B) Gravimetric analysis Theoretical aspects of precipitation; weight determinations without sample transformation, weight determinations with sample transformation, precipitation of a compound in homogeneous phase, coprecipitation, glassware in use in gravimetric analysis; Weight determination of a precipitate: precipitation, digestion, filtration, washing, drying and calcination, gravimetric factor C) Instrumental analysis Electrochemical methods: Potentiometric analysis: generalities; liquid junction potential; the membrane potential; salt bridge; electrode potentials; reference electrodes: hydrogen; calomel; silver, silver chloride; metal and membrane indicator electrodes; glass electrode; pH measurement; alkaline error, acid error. Combination electrodes. Conductivity analysis: general concepts; conductivity, specific conductivity; equivalent conductivity; factors affecting conduction mechanisms: solution ion concentration; ionic charges; migration velocity; electrophoretic effect, asymmetry effect, temperature. Conductivity measurements: conductivity meter; conductometric titrations: strong acid strong base; weak acid strong base; titrations with precipitate formation. HPLC: introduction, chromatography (introduction, general and specific factors influencing subsequent quantification) , detectors, quantification, AUC Optical methods of analysis: Electromagnetic radiation; wavelength, amplitude, frequency, wave number, intensity. The electromagnetic spectrum; Applications of spectroscopy in analytical chemistry: molecular spectroscopy; UV-Visible spectroscopy; infrared spectroscopy. Interaction between molecules and radiant energy; Lambert and Beer's law, chemical and instrumental deviations. Principles of UV-Vis Spectroscopy: HOMO-LUMO transitions; legal and illegal transitions; chromophores, auxochromes; batochrome, hypsochrome, hyperchrome effect. The isosbestic point. Factors influencing absorption: solvent, pH, steric hindrance. Quantitative analysis: UV-Vis single-beam and double-beam spectrophotometer instrumentation; monochromators, detectors.

Passing the General Chemistry examination is mandatory, with particular emphasis on knowledge of: formation of salts, balancing reactions, acid-base equilibria, pH calculation, hydrolysis reactions, redox reactions, solubility equilibria. Passing the course in Organic Chemistry and Qualitative Analysis of Official Pharmacopoeia Compounds is recommended.

Skoog, West, Holler, Fondamenti di Chimica Analitica, Ed Edises G. C. Porretta Analisi di preparazioni farmaceutiche – Analisi Quantitativa – Ed CISU R. Cozzi, P. Protti, T. Ruaro. Analisi Chimica Strumentale. A. Metodi Elettrochimici, Zanichelli Bologna R. Cozzi, P. Protti, T. Ruaro. Analisi Chimica Strumentale. A. Metodi Ottici, Zanichelli Bologna

The integrated course aims to provide the student with theoretical and practical skills in the different fields of the quantitative analysis of compounds of pharmaceutical interest, theoretical-practical learning in which the student learns the theoretical principles of analytical methodologies and practical laboratory activities for the quantification of compounds in the Official Pharmacopoeia (F.U). through classical and modern methods. - Knowledge and understanding - Knowledge and understanding: the student gains the necessary knowledge for the quantitative recognition of compounds of pharmaceutical interest as listed in the European Pharmacopoeia and the Italian Official Pharmacopoeia. - Applied knowledge and understanding - Applying knowledge and understanding: the student is able to use the acquired knowledge in order to choose an analytical methodology for the quantification of compounds of pharmaceutical interest. - Autonomy of judgement - Making judgements: the student develops critical and experimental observation skills by integrating the theoretical and practical notions acquired in frontal and laboratory lectures. - Communication skills - Communication skills: the student develops the ability to describe in a concise and rigorous manner the concepts learned in theoretical and practical lectures. The student also acquires the ability to work in a team and to clearly communicate his or her knowledge or research results, both to an audience of specialists and to a wider audience of non-specialists. - Learning skills: the student develops a better understanding of the topics covered in the course in order to autonomously select the appropriate sources for the application of analytical methods and experimental protocols in pharmaceutical quantitative analysis, drawing on official reference texts and bibliography, in Italian and English, leading to the possibility of better addressing the courses of the following years, thanks to a greater awareness of the topics covered.

The examination will be conducted in oral and written form. A mark of no less The student must demonstrate sufficient knowledge of the main topics covered in the course, with particular emphasis on the different areas of quantitative analysis of compounds of pharmaceutical interest. Honours will be awarded, subject to a mark of 30/30, to students who have demonstrated a superior level of knowledge and in-depth study of the subjects with autonomy of study, appropriateness of language and excellent communication skills. During the examination, the student's preparation will be tested by means of questions requiring the solution of an analytical problem that could occur in the laboratory. The solution of these problems requires the application of simple calculations. The laboratory exercises will be taken into account. The final grade will be an overall assessment of the practical work and the oral interview. Knowledge and ability to understand - The examination, carried out orally, enables the level of knowledge attained by the student to be assessed and the understanding of the concepts to be deepened; Applied knowledge and ability to understand - At the oral examination, the student will present the laboratory notebook in which he/she will have reported all the exercises carried out during the course and the ability to use the concepts learned in the analysis of inorganic pharmacopoeia compounds will be assessed; Autonomy of judgement - During the oral test, the student must demonstrate the ability to evaluate and define a methodological proposal suitable for the different analytical problems required. Communication skills - During the oral test, the student will have to argue and express the knowledge acquired using appropriate technical-scientific language; Ability to learn - The presence of a solid scientific basis in terms of knowledge of the analytical properties of compounds of pharmaceutical interest and the ability to integrate this theoretical knowledge with the practical skills developed in laboratory lessons will be assessed, in order to define the level of autonomy in carrying out future experiments.

The course aims to provide the student with theoretical and practical skills in the quantitative analysis of medicinal products through lectures and laboratory exercises. At the end of the integrated course, the student must demonstrate that he/she has acquired the following objectives: - Knowledge and understanding - Knowledge and understanding (Dublin 1): the development of the knowledge defined in the learning objectives is achieved through theoretical lectures supported by practical laboratory lectures carried out individually. - Applied knowledge and understanding - Applying knowledge and understanding (Dublin 2): the theoretical and practical notions acquired during the course enable the student to autonomously evaluate the experimental methodology suitable for the quantitative recognition of compounds of pharmaceutical interest in the Pharmacopoeia. - Autonomy of judgement - Making judgements (Dublin 3): the performance of laboratory exercises carried out individually and supported by theoretical knowledge acquired during the lectures enable the student to autonomously and critically evaluate the experiments conducted and to autonomously carry out observations and experiments based on the laboratory activities learnt. - Communication skills - Communication skills (Dublin 4): the drafting of a laboratory notebook containing the information relating to the exercises carried out, together with the continuous discussion with the lecturer and the other students during the exercises, will help the student to clearly and concisely illustrate the information obtained from the various experiments, also favouring the use of suitable technical scientific language. - Learning skills (Dublin 5): Lectures allow the student to create a solid base in terms of knowledge of analytical methods of compounds of pharmaceutical interest. The integration of such theoretical knowledge with the practical skills developed in the laboratory lessons will favour an increase in autonomy in the realisation of future experiments, defining experimental protocols on the basis of the literature consulted by drawing on reference texts and bibliography, in Italian and English.