PHRM07018 2019 PHARMACEUTICAL ANALYSIS

General Details

Full Title
PHARMACEUTICAL ANALYSIS
Transcript Title
PHARMACEUTICAL ANALYSIS
Code
PHRM07018
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
10 - 10 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Fiona McArdle, Geraldine Duignan, Carmel Moran, Tom Patton
Programme Membership
SG_SPHAR_B07 201900 Bachelor of Science in Pharmaceutical Science SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science
Description

This module addresses the essential practical and theoretical aspects of pharmaceutical analysis with a particular focus on separation science.

Students will  engage in testing and reporting on the quality of a selection of pharmaceutical APIs and finished products using both compendial and non-compendial methods with due consideration to GMP throughout. 

The module also addresses the issues of quality within measurements and also addresses aspects of sample preparation and pretreatment. 

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

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

2.

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

3.

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

4.

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

5.

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

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

7.

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

Teaching and Learning Strategies

This module will be taught through a variety of modes including lectures, tutorials and laboratory sessions - with individual and Team Based approaches

The aim is to blend theory and practice in gradually more applied contexts, and to allow students opportunities to self assess, explore and learn from each other within the clear framework of quality analytical methods established in compendial texts for pharmaceutical analysis and regular feedback from staff.

Beginning:  Week 1-4:Individual students work to  establish current competency levels and identify individual learning goals. Theory revises basic functional group chemistry and physicochemical properties related to a selection of  pharmaceutical compounds and laboratory activities centre around independence in basic laboratory competencies from yr 2.  Students will have the opportunity to learn from each other and peer review each others work but the focus is on individual competency. 

Middle: Week (5-10) Team focussed laboratory sessions tutorial workshops are used to allow student groups to plan, execute valid laboratory analyses using compendial and non-compendial methods and to report on results with due consideration of documentation requirements for GMP.   Lectures are provided concurrently on important fuctional aspects of the techniques used.  Students take individual responsibility for documentation, interpretation and reporting or results.

End: Demonstration of advanced techniques and Individual competencies are reviewed (Week 11-12) 

Module Assessment Strategies

This module is 65% continuous assessment 50% practical and 15% continuous assessment theory and 35% final examination.The students must reach an assigned gate (30%) in the final examination and achieve 40% overall to pass the module

SUMMATIVE:

Practical skills, report writing and data evaluation will be assessed at regular intervals (2-3 weeks). (50%)

Theory Assignment:  Based on Application notes (15%)

Final exam (35%)

FORMATIVE:  Short questions,  MCQs  and simulated data for interpretation will be used formatively in workshops and on the moodle platform.

 

Repeat Assessments

Repeat exam if grade in final exam is <30%

Repeat attendance may be required if attendance is less than 75% in practical sessions.

Repeat CA if all other conditions have been met and student has failed to achieve passing grade.

Module Dependencies

Prerequisites
CHEM06047 201900 PHARMACEUTICAL ANALYTICAL METHODS CHEM06046 201900 PHYSICAL CHEMISTRY CHEM06028 201900 FOUNDATION CHEMISTRY
Co-requisites
None
Incompatibles
None

Indicative Syllabus

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.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
65 %
End of Semester / Year Formal Exam
35 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Short questions and practical assessments Formative Assessment - % Week 2 1,2,3,6,7
2 Laboratory Reports Continuous Assessment Written Report 40 % OnGoing 3,5,6,7
3 Assignment Continuous Assessment Assignment 15 % Week 6 2,4,7
4 Independently perform analysis Practical Practical Evaluation 10 % Week 11 6,7

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Closed Book Exam 35 % End of Semester 1,2,3,4,5,7
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 2 Weekly 2.00
Problem Based Learning Problem Based Learning Room Problem Based Learning 1 Weekly 1.00
Independent Learning Not Specified Self study 8 Weekly 8.00
Laboratory Practical Science Laboratory Pharmaceutical Analysis Practical 3 Weekly 3.00
Total Full Time Average Weekly Learner Contact Time 6.00 Hours

Required & Recommended Book List

Required Reading
2016-07-26 Pharmaceutical Analysis Elsevier
ISBN 0702069892 ISBN-13 9780702069895

Pharmaceutical analysis forms a core part of any pharmacy programme, as well as being essential for pharmacology and medicinal chemistry courses. Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of analyses, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. The mathematics involved is notoriously difficult, but this much-praised textbook, now revised and updated for its fourth edition, guides a student through the complexities with clear writing and the author's expertise from many years' teaching pharmacy students. There is continuous learning reinforcement throughout the book by way of worked calculation examples and self-assessment test questions. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes New chapter on electrochemical biosensors. New chapter on the quality control of biotechnologically produced drugs. Extended chapter on molecular emission spectroscopy. Now on StudentConsult. ~

Required Reading
2007-10-08 Quality Assurance in Analytical Chemistry Wiley-Interscience
ISBN 047001203X ISBN-13 9780470012031

The issue of quality assurance in the analytical chemistry laboratory has become of great importance in recent years. Quality Assurance in Analytical Chemistry introduces the reader to the whole concept of quality assurance. It discusses how all aspects of chemical analysis, from sampling and method selection to choice of equipment and the taking and reporting of measurements affect the quality of analytical data. Finally, the implementation and use of quality systems are covered.

Required Reading
2015-05-29 Quantitative Chemical Analysis WH Freeman
ISBN 131915414X ISBN-13 9781319154141

The gold standard in analytical chemistry, Dan Harris Quantitative Chemical Analysis provides a sound physical understanding of the principles of analytical chemistry and their applications in the disciplines. Dan Harris presents the subject in a rigorous, readable and interesting manner, lucid enough for non-chemistry majors but containing the depth required by advanced undergraduates. For the first time since the book was published in 1978, Harris has worked with a new contributing author, Professor Chuck Lucy of the University of Alberta. Lucy shares his expertise and teaching experience in Chapters 23-26 on chromatography and capillary electrophoresis.

Module Resources

Non ISBN Literary Resources

The British Pharmacopoeia 2019

The European Pharmacopoeia  9th Ed.

Handbook of Pharmaceutical Analysis by HPLC, Satinder Ahuja, Michael Dong, Elsevier, 2005.

 

Journal Resources

Journal of Pharmaceutical and Biomedical analysis: ISSN: 0731-7085, 

Additional Information

None