PHRM07011 2020 Pharmaceutical Analysis

Describe the purpose of the most common analytical tests carried out in the context of pharmaceutical manufacturing and quality control.

Relate key structural and physicochemical properties of pharmaceutical compounds to their analysis: eg appropriate analytical techniques, sample preparation and analytical conditions

Identify suitable sample preparation techniques for a variety of pharmaceutical samples

Perform qualitative and quantitative laboratory analyses  on Pharmaceutical APIs and Finished Products using a selection of compendial and non-compendial methods and with due consideration of GLP/GMP

Interpret data from qualitative and quantitative chromatographic determinations in relation to a stated test hypothesis or quality specification

This module will be delivered to online. This will include lectures and laboratory practicals augmented by independent learning and directed learning. Attendance at a workshop to complete the laboratory practicals is mandatory. Exemption from attending the workshop may be considered where a student can demonstrate that the learning outcomes of the practicals can be achieved through a work-based project. Moodle will be used as a repository of educational resources and as a means of assessment (e.g. quizzes, uploading assignments and journals).

This module is 65% continuous assessment and 35% final exam.

Students will be assessed using Moodle based multiple choice and short answer questions, laboratory performance and results, and reinforced with a final written examination.

Repeat Continuous Assessment and/or Final Exam.

1. Describe the purpose of the most common analytical tests carried out in the context of pharmaceutical manufacturing and quality control.  

• Role of QC in pharmaceutical manufacturing environment
• Compendial methods: Identity, Impurities/related substances, Assay, other characteristics. 

2. Relate key structural and physicochemical properties of pharmaceutical compounds to their analysis: eg appropriate analytical techniques, sample preparation and analytical conditions. 

• Intermolecular interactions, partition coefficients, ionisation pka/buffers, sterochemistry.

3. Identify suitable sample preparation techniques for a variety of pharmaceutical samples:

• Solubility, filtration, centrifugation, solvent extraction, solid phase extraction.

4. Explain the chemistries of some of the phases used in instrumental chromatographic techniques.

• Mobile and stationary phase chemistries: HPLC/UPLC, GC, Ion Chromatography, 

5. Explain what is meant by a valid analytical method and the steps taken to ensure validity in analysis. 

• Validation requirements ICHQ2
• System suitability requirements PhEur

6. Perform qualitative and quantitative laboratory analyses  on Pharmaceutical APIs and Finished Products using a selection of compendial and non-compendial methods and with due consideration of GLP/GMP

In relation to Assays and Related Substances reviewing use of  Chemical (titration) & spectroscopic (FTIR/UV) techniques and emphasising competencies in performing chromatographic separations: HPLC (in particular), GC, Ion Chromatography. 

• Identify relevant hazzards and manage risks for safety.
• source and apply compendial method or non-compendial SOP
• Prepare samples/standards and set up instrumentation
• Record all relevant data in consideration of GLP/GMP

7. Interpret data from qualitative and quantitative chromatographic determinations in relation to a stated test hypothesis or quality specification.

• Quality specifications for pharmaceutical samples. 
• Recording and documenting 
• Processing qualitative and quantitative analytical data
• Interpretation of chromatographic data including system suitability - in relation to quality specification