This module aims to provide the student with a knowledge of the fundamental concepts of chemistry as appropriate to the production of drug products. The module sets out the principles of atomic structure, chemical structures of inorganic/organic compounds and fundamentals of their analysis.
Introduction to Standards and Measurements
Units of measurement in chemistry; temperature units and conversisons
Atomic and Molecular Structure
States of matter, elements, atoms, molecules, atomic structure. Structural basis for chemical behaviour, valency and chemical bonding. Polar molecules, intermolecular bonding, hydrogen bonding and the structure of water. Hydrophilic and hydrophobic substances, solubility. The periodic table. Physical properties of compounds, vapor pressure, particle size analysis.
Chemical Calculations and Analysis
Atomic and molecular mass, the mole concept, balanced chemical equations. Calculations based on balanced equations. Reaction yield – examples based on batch processes. Concentration: mass/volume, molarity, ppm, etc. Standard solutions, dilution calculations. Estimation of purity, limit tests. Overview of chromatographic and other analytical techniques for product analysis.
Inorganic Substances
Acids, bases, salts. Reactions: neutralization, oxidation, precipitation. Strong and weak acids and bases. pH calculation and measurement, buffers, calibration of pH meters, titrations; Chemical equilibrium; Redox properties of elements and compounds.
Organic Chemistry
Importance and structure of organic compounds. Functional groups and classification based on functional group. Properties of organic substances. Structure of some pharmaceutically important molecules. Bio-molecules, Polymers, Acid and basic organic molecules. Extraction and phase separations. Examples of relevant organic reactions based on the company’s products. Safety considerations. Product isolation, crystallization, distillation and extraction.
Chemistry of Heat and Gases
Introduction to theromchemistry and specific heat; Gas properties and the Gas Laws.
Sample Practicals
Calibrate a pH meter, measure the pH of an acid and a base and carry out a titration. Prepare and use a simple acid/base buffer.Prepare standers by dilution for spectrophotometric analysis in the context of a cleaning validation.Estimate the purity of a recovered solvent by GC analysis.Carry out a simple organic synthesis including product purification.Prepare a safety review of all raw materials and process waste for a particular chemical process.Specify the material requirements for a process batch and calculate yields for the batch.Examine the specifications for a chemical raw material and explain the meaning of each of the specifications.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 50 |
| Formal Examination | 50 |