Books from MTS

MTS offers two books on topics relating to the chemical analysis of pharmaceuticals. The books are written by Oona McPolin, the MTS trainer and consultant. They provide practical and current information. The topics available are method validation and introductory HPLC, both applied to pharmaceutical analysis.

Validation of Analytical Methods for Pharmaceutical Analysis

A nicely written handbook on how to perform validation of methods used in pharmaceutical analysis.” – Chemistry World, Royal Society of Chemistry

Book cover for Validation of Analytical Methods for Pharmaceutical Analysis

Overview:

A full review of the available regulatory guidelines on validation and in particular, those from the International Conference on Harmonisation (ICH). Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat.

Features:

  • Thorough discussion of each of the validation characteristics: Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability; plus practical tips on how they may be studied.
  • What to include in a validation protocol, with advice on the experimental procedure to follow and selection of appropriate acceptance criteria.
  • How to interpret and calculate the results of a validation study, including the use of suitable statistical calculations.
  • A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.

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ISBN: 978-0-9561528-1-7

Format: Paperback, 210 x 300mm (A4), 152 pages

Publisher: Mourne Training Services Ltd

An Introduction to HPLC for Pharmaceutical Analysis

A brief well-written guide and resource to assist the analyst in the use of HPLC in a pharmaceutical analysis environment.” – Chemistry World, Royal Society of Chemistry

Book cover for An Introduction to HPLC for Pharmaceutical Analysis

Overview:

This book is aimed at those who are new to HPLC. Whether you are a new starter in an analytical laboratory, an experienced scientist new to HPLC, a recent graduate, or a student, it provides an invaluable guide about how HPLC is actually used when analysing pharmaceuticals.

Features:

  • A thorough discussion of the stationary phase enabling the reader to make sense of the many parameters used to describe an HPLC column.
  • Practical advice and helpful hints for the preparation and use of mobile phase.
  • A complete overview of each of the different components which together make up an HPLC system.
  • A description of the contents of a typical HPLC analytical method and how to interpret these.
  • A step-by-step guide on how to follow a method and set up an HPLC analysis.
  • A discussion of system suitability criteria and how to interpret the values obtained during an analysis.
  • Explanation of the common methods of calibration and quantification used for pharmaceutical analysis.

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ISBN: 978-0-9561528-0-0

Format: Paperback, 210 x 300mm (A4), 148 pages

Publisher: Mourne Training Services Ltd

Cost and Shipping

Both books cost £29.00 GBP plus shipping. Shipping is FREE to UK and Ireland addresses and is very reasonably priced for other locations at only £3.50 GBP for Europe and £5.50 GBP for the rest of the world. The shipping time depends on your location and is typically less than 14 days from the date of the order.

You can purchase single copies of either book using the PayPal button provided but contact us if you would like a quotation for a larger order.