production
Skip to Content

CM5541: ANALYTICAL METHODS FOR PHARMACEUTICAL ANALYSIS (2021-2022)

Last modified: 31 May 2022 13:05


Course Overview

This course will provide an introduction to the key analytical methods used in drug development and how to develop methods consistent with the demands of the regulatory authorities. Students will gain hands-on experience of the techniques described.

Course Details

Study Type Postgraduate Level 5
Session Second Sub Session Credit Points 15 credits (7.5 ECTS credits)
Campus Aberdeen Sustained Study No
Co-ordinators
  • Dr Rainer Ebel
  • Dr Rebecca Walker

What courses & programmes must have been taken before this course?

  • Any Postgraduate Programme

What courses cannot be taken with this course?

  • CM5941 Analytical Methods for Pharmaceutical Analysis (Studied)

Are there a limited number of places available?

No

Course Description

A wide range of relevant analytical methods will be described including: titration; water analysis (Karl Fischer); MPLC, HPLC and HPLC-MS (normal and reverse phase, analytical and preparative); NMR spectroscopy; IR spectroscopy; UV-vis spectroscopy; metal analysis using ICPMS; ion chromatography for counter-ion analysis; GC, GC headspace and GC-MS.

The principles of method validation will be discussed within the framework of the regulatory expectations of ICH guidance. The factors to be considered in generating a certificate of analysis (CoA) will be considered. The students will gain hands-on experience of each of these techniques in the associated laboratory classes.


Details for second half-session courses, including assessments, may be subject to change until 23 December 2022.

Contact Teaching Time

Information on contact teaching time is available from the course guide.

Teaching Breakdown

More Information about Week Numbers


Details for second half-session courses, including assessments, may be subject to change until 23 December 2022.

Summative Assessments

Oral Presentation: Group

Assessment Type Summative Weighting 50
Assessment Weeks 29 Feedback Weeks 29

Look up Week Numbers

Feedback

In setting of a ‘client meeting presentation’. Maximum group size of 5. Marked on presentation, questions & peer assessment and data quality so that each student gets a unique grade.

Learning Outcomes
Knowledge LevelThinking SkillOutcome
ProceduralApplyUnderstand the application of chromatographic techniques for pharmaceutical analysis.
ProceduralCreateDemonstrate the ability to conduct an independent analysis using GC, LC and other modern chromatographic techniques
ProceduralEvaluateGain an understanding of method development for the techniques described
ProceduralEvaluateUnderstand and evaluate the parameters and requirements for method validation.
ReflectionEvaluateDemonstrate the ability to prepare a certificate of analysis.

Report: Individual

Assessment Type Summative Weighting 50
Assessment Weeks 32 Feedback Weeks 34

Look up Week Numbers

Feedback

Solving structures based on spectra – each student will be provided a different set of spectra

written feedback

Learning Outcomes
Knowledge LevelThinking SkillOutcome
ProceduralAnalyseUnderstand the application of spectroscopic techniques for pharmaceutical analysis.
ProceduralEvaluateGain an understanding of method development for the techniques described
ProceduralEvaluateUnderstand and evaluate the parameters and requirements for method validation.

Formative Assessment

There are no assessments for this course.

Resit Assessments

Resubmission of failed individual assessment

Assessment Type Summative Weighting
Assessment Weeks Feedback Weeks

Look up Week Numbers

Feedback
Learning Outcomes
Knowledge LevelThinking SkillOutcome
Sorry, we don't have this information available just now. Please check the course guide on MyAberdeen or with the Course Coordinator

Course Learning Outcomes

Knowledge LevelThinking SkillOutcome
ProceduralEvaluateGain an understanding of method development for the techniques described
ProceduralAnalyseUnderstand the application of spectroscopic techniques for pharmaceutical analysis.
ProceduralApplyUnderstand the application of chromatographic techniques for pharmaceutical analysis.
ReflectionEvaluateDemonstrate the ability to prepare a certificate of analysis.
ProceduralCreateDemonstrate the ability to conduct an independent analysis using GC, LC and other modern chromatographic techniques
ProceduralEvaluateUnderstand and evaluate the parameters and requirements for method validation.

Compatibility Mode

We have detected that you are have compatibility mode enabled or are using an old version of Internet Explorer. You either need to switch off compatibility mode for this site or upgrade your browser.