PHRM07011 2020 PHARMACEUTICAL ANALYSIS

General Details

Full Title
PHARMACEUTICAL ANALYSIS
Transcript Title
PHARMACEUTICAL ANALYSIS
Code
PHRM07011
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
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Yvonne Lang
Programme Membership
SG_SPHAD_B07 201900 Bachelor of Science in Pharmaceutical Science
Description

This module covers the essential aspects of separation science for pharmaceutical samples. It addresses the issues of quality within measurements and examines the various sample types encountered within the pharmaceutical industry. It 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.

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

5.

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 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).

Module Assessment Strategies

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 Assessments

Repeat Continuous Assessment and/or Final Exam.

Module Dependencies

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 Continuous Assessment Closed Book Exam 15 % OnGoing 1,2,3,4,5
2 Practical Portfolio Practical Individual Project 50 % Week 10 1,2,3,4,5
             

End of Semester / Year Assessment

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

Online Learning Mode Workload


Type Location Description Hours Frequency Avg Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00
Workshop Science Laboratory Practical Workshop 30 Once Per Semester 2.00
Independent Learning Not Specified Self study 2 Weekly 2.00
Total Online Learning Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Recommended Reading
2016-07-26 Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists, 4e Elsevier
ISBN 0702069892 ISBN-13 9780702069895
Recommended Reading
2008-01-01 Quantative Chemical Analysis W.H. Freeman & Company
ISBN 0716770415 ISBN-13 9780716770411

New, ship fast, delivered in 5 days in UK. No PO Box.

Recommended Reading
2013-01-01 Fundamentals of Analytical Chemistry Brooks Cole
ISBN 9780495558286 ISBN-13 9780495558286

Known for its readability and systematic, rigorous approach, this fully updated Ninth Edition of FUNDAMENTALS OF ANALYTICAL CHEMISTRY offers extensive coverage of the principles and practices of analytic chemistry and consistently shows students its applied nature. The book's award-winning authors begin each chapter with a story and photo of how analytic chemistry is applied in industry, medicine, and all the sciences. To further reinforce student learning, a wealth of dynamic photographs by renowned chemistry photographer Charlie Winters appear as chapter-openers and throughout the text., Incorporating Excel spreadsheets as a problem-solving tool, the Ninth Edition is enhanced by a chapter on Using Spreadsheets in Analytical Chemistry, updated spreadsheet summaries and problems, an "Excel Shortcut Keystrokes for the PC" insert card, and a supplement by the text authors, EXCEL (R) APPLICATIONS FOR ANALYTICAL CHEMISTRY, which integrates this important aspect of the study of analytical chemistry into the book's already rich pedagogy. New to this edition is OWL, an online homework and assessment tool that includes the Cengage YouBook, a fully customizable and interactive eBook, which enhances conceptual understanding through hands-on integrated multimedia interactivity. Available with InfoTrac (R) Student Collections http://gocengage.com/infotrac.

Module Resources

Other Resources

British Pharmacopoeia

European Pharmacopoeia

US Pharmacopoeia