Chemical, Biochemical and Spectroscopic Analytical Methods

Overview

Summary of Lecture Content:

Semester 1
Lecture Topic Staff
1 Principles of Pharmaceutical Analysis (1) Sudhirkumar Shinde
2 Principles of Pharmaceutical Analysis (2) Sudhirkumar Shinde
3 Basic spectroscopic principles (1) Steven Bell
4 Basic spectroscopic principles (2) Steven Bell
5 Ultraviolet spectroscopy AP de Silva
6 Fluorescence spectroscopy AP de Silva
7 Titrimetric methods of analysis Sudhirkumar Shinde
8 Mass spectrometry (1) Panagiotis Manesiotis
9 Mass spectrometry (2) Panagiotis Manesiotis
10 NMR (1) Gosia Swadzba-Kwasny
11 NMR (2) Gosia Swadzba-Kwasny
12 Applied NMR spectroscopy Gosia Swadzba-Kwasny
Semester 2
13 BP standard chemical assay and pharmaceutical analysis Justin Tian
14 Applied analysis in solid dosage form development Justin Tian
15 Process-driven innovations in pharmaceutical analysis Justin Tian
16 Analysis of Biopharmaceutical Agents Wafa Al-Jamal
17 Formulated biologicals and analysis Wafa Al-Jamal
18 Microbiological Analyses Laura Sherrard
19 Enzyme Immunoassays Deirdre Gilpin
20 Radiochemistry and applications Laura Sherrard
21 Pharmacopoeias and Official Standards Garry Laverty
22 Data presentation of biological information: data handling/ processing/reporting Laura Sherrard

Summary of Practical Content:
• Workshop 1 & Practical 1: UV-Vis and Fluorescence spectroscopy.
• Workshop 2 & Practical 2: NMR spectroscopy.
• Workshop 3 & Practical 3: Mass spectrometry.
• Practical 4: Total protein assay.
• Practical 5: Phosphate assay.
• Practical 6: Assay of ibuprofen in commercial tablets.

Learning Objectives

This module will provide an extensive overview of the theoretical principles and the design and operating principles of a range of spectroscopic instruments. Methodologies relating to the use of such instruments in qualitative and quantitative analysis of pharmaceutical and related products will be extensively covered and specifically related to analytical aspects of Pharmacopoeia monographs. The module will cover the design, workings and operating principles of a range of analytical techniques that are commonly used to characterise the physicochemical properties of finished products. It will also introduce, briefly, the cutting-edge innovations in pharmaceutical analysis for global pharmaceutical industry.

At the end of the module the students are expected to:
• Have a sound understanding of the theoretical and practical aspects of key chemical, biological and spectroscopic methods applied to the analysis of Active Pharmaceutical Ingredients and excipients.
• Read, understand and assimilate new information and subsume acquired knowledge into a concise format.
• Reflect on experimental outcomes and use this in relation to overcoming analytical method development orientated problems.
• Demonstrate problem solving skills.
• Perform advanced mathematical and statistical manipulation of data.
• Demonstrate effective written and oral communication skills, including preparation and presentation of technical reports based on experimental results.
• Be able to work in a team, through participation in group projects.
• Demonstrate critical thinking through the validation of information (personal and literature data) and the application of theoretical knowledge to practical method development and problem solving.
• Demonstrate a sound understanding of how to select and develop advanced analytical techniques and procedures to be used in the analysis of pharmaceutical and related products.
• Have developed the practical and related skills required to generate data and produce appropriate reports and SOPs in a GMP environment.
• Aware of current trends in pharmaceutical R&D, manufacture and associated innovations in pharmaceutical analysis department.

Skills

• Ability to prioritise activities and plan lab practical.
• Obtain and record relevant analytical data in correct format.
• Ability to perform data handling, interpretation of results and formulating conclusions.
• Ability to review literature, to produce written documents, including SOPs and written reports.
• Ability to perform statistical interpretation of data.

Assessment

Assessment:
Examination 70 % (3 hours)
Coursework 30 %

Course Requirements:
Coursework submission 100 %
Laboratory Class attendance 100 %
Examination theory Veto 50 %

Both the exam and total coursework elements must be passed at 50%.