Drug Analysis 2 and Laboratory of Drug Analysis 2

Lessons
- Introduction to drug analysis - Qualitative and quantitative elemental analysis of organic compounds - Tests to identify organic chemical functions: alcohols, polyalcohols, phenols, ketones and aldehydes, sugars, carboxylic acids and derivatives, amines, amino acids, heterocyclic compounds - Tests to identify classes of compounds of medicinal interest.
Solubility, partition coefficient, extraction techniques, ternary solubility diagrams - The solid state and its characterization (melting point, polymorphism, binary phase diagrams) - The liquid state and its characterization (boiling point, fractional distillation, phase diagrams of binary liquid mixtures) - Thermal analysis (TGA, TA DSC) - Refractometry - Polarimetry - Circular dichroism - Chiral compounds: chiroptical properties and analytical methods to determine enantiomeric composition - NIR spectroscopy and PCA analysis.

Individual laboratory training
Introduction to the analysis of organic, organometallic, and inorganic compounds listed in the EP. Combustion tests on porcelain crucibles and analysis of the residue. Elemental analysis using Lassaigne's solution for the detection of nitrogen, sulfur, and halogens. Detection of halogens and phosphorus by calcination. Determination of cations in organometallic substances. Study of solubility in water, acids, bases, and organic solvents. Melting point determination. Tests for the identification of: aromaticity, double bonds, alcohols, aldehydes, ketones, polyalcohols, sugars, carboxylic acids, phenols, amines, amino acids, esters, amides. General and specific tests for the identification of sulfonamides, xanthines, alkaloids, glycosides, vitamins, and various other substances. Overview of the identification of anions and cations in inorganic substances. Instrumental analysis using UV spectrophotometry, polarimetry, and HPLC. Examination of substances listed in the EP and their identification through the techniques illustrated during the course

Drug Analysis II
The Drug Analysis II and Drug Analysis Laboratory II courses, consisting of lectures and individual practical exercises, aim to develop specific competencies in qualitative chemical analysis applied to the development and production of synthetic, biotechnological, and naturally sourced pharmaceuticals.
Additional topics of pharmaceutical analytical character will also be addressed, including:
· Therapeutic drug monitoring
· Identification of counterfeit medications
· Introduction to the analytical aspects of the drug discovery process
Particular attention will be devoted to methods outlined in official pharmacopoeias, with specific reference to the current European Pharmacopoeia (EP). In addition, tools will be provided for developing original analytical procedures for physicochemical characterization, structural identity, purity, and stability of new chemical entities.

Topics of Drug Analysis II Lectures
The topics of the lectures can be divided into three main groups:
1. Chemical Analysis of Substances Included in the EP
· Introduction to the principles of pharmaceutical analysis according to the EP
· Classification of substances: organic, organometallic, inorganic
· Solubility according to the EP
· Qualitative elemental analysis
· Study of chemical reactivity and recognition reactions for main functional groups:
o Olefinic double and triple bonds, aromatic systems, π-conjugation systems
o Alcoholic, ether, phenolic, carbonyl, carboxyl, ester, amide, amine, nitro, sulfonic, and sulfonamide groups
· General and specific recognition analyses and reactions for:
o Amino acids and proteins
o Alkaloids, local anesthetics, antibiotics, barbiturates, carbohydrates and glycosidic derivatives, steroids, sulfa drugs, vitamins
· Specific recognition reactions for individual drugs
2. Instrumental Analysis: Principles and Applications
· Instrumental analytical methods for the determination of partition coefficient
· Sample preparation: application of extraction and chromatographic techniques
· Quantitative elemental analysis
· Determination of molecular formula using high-resolution mass spectrometry
· Solubility: thermodynamic aspects, structure-solubility relationships, determination of solubility via kinetic and thermodynamic methods
· Determination of physical constants: melting point, boiling point, density, refractometry and refractive index, polarimetry, and specific optical rotation
· Chromatographic, spectroscopic (UV-VIS, Raman), and spectrometric techniques for the identification and characterization of pharmaceutical compounds and their impurities
· Hyphenated techniques (HPLC-MS, HPLC-UV)
· Calorimetric techniques (TGA, DSC, DSC-TGA)
· X-ray diffractometric analysis
· Criteria for selecting and applying instrumental techniques based on the specific analytical problem
3. Specific Analytical Applications
· Characterization of pharmaceuticals and their impurities
· Analysis of herbal drugs
· Analysis of biotechnological pharmaceuticals
· Identification of counterfeit medications
· Introduction to the analytical aspects of drug discovery

Module: Laboratory of Drugs Analysis II
Introduction to the analysis of organic, organometallic, and inorganic compounds listed in the EP. Combustion tests on porcelain crucibles and analysis of the residue. Elemental analysis using Lassaigne's solution for the detection of nitrogen, sulfur, and halogens. Detection of halogens and phosphorus by calcination. Determination of cations in organometallic substances. Study of solubility in water, acids, bases, and organic solvents. Melting point determination. Tests for the identification of: aromaticity, double bonds, alcohols, aldehydes, ketones, polyalcohols, sugars, carboxylic acids, phenols, amines, amino acids, esters, amides. General and specific tests for the identification of sulfonamides, xanthines, alkaloids, glycosides, vitamins, and various other substances. Overview of the identification of anions and cations in inorganic substances. Instrumental analysis using UV spectrophotometry, polarimetry, and HPLC. Examination of substances listed in the EP and their identification through the techniques illustrated during the course.