2.34906 PHARMACEUTICAL QUALITY CONTROL

The aim of the course is to introduce students to the basic issues for the control of quality in pharmaceutical products. On completion of the course the students should be able to: explain the purpose of capsules as a dosage form; evaluate basic properties of capsule dosage forms; other forms of capsules including micro capsules and nanocapsules; to appreciate the importance and need of high quality packaging materials as an integral component of drug products; and to demonstrate an understanding of basic standard and physical tests employed in its maintenance. Topics include: Pharmacopoeial standards, purity and limit tests for drug products, controls on excipients and non-pharmacopoeia materials, microbial tests, standards for potable water, sources of products and certificate of analysis, physical testing including melting point, boiling point, density, viscosity, specific gravity, optical rotation, and identification tests for drugs and related materials.

Contact: 6 hours per week (2 Lectures, 1 Tutorial and 3 hour practical).

Assessment: Tests, assignments, practicals (60%), final exam (40%).

Text:

A. H. Becket & J. B. Stenlake, 1988, Practical Pharmaceutical Chemistry, Parts I and II, 4th Edn., Athlone Press, London