Pharmaceutical impurities workshop
Workshop
Nov 27, 2018 - Nov 27, 2018

Hands-On Pharmaceutical Impurities Workshops

Impurity analysis is an essential part of pharmaceutical manufacture and subsequent storage as pharmaceutical impurities can be pharmacologically and toxicologically active and can also reinforce or diminish the pharmacological efficacy of the active pharmaceutical ingredient (API). For these reasons it is critical to identify and quantitate pharmaceutical impurities.

In this one-day workshop you will gain:

  • Information on pharmaceutical impurities and associated regulations
  • Analytical options available for the identification, characterization and quantitation of both organic and inorganic pharmaceutical impurities
  • Strategies to improve analysis throughput and robustness
  • Practical, hands-on, experience of analyzing and quantitating pharmaceutical impurities of Ibuprofen by LC-MS, ICP-MS and IC-MS
  • The use and importance of reference standards in the workflow
  • Tips and tricks from experts for successful pharmaceutical impurity analysis

These events will appeal to both new and recent entrants to the field of pharmaceutical impurities looking to increase knowledge as well as more experienced analysts looking for ways to enhance and improve efficiency of current workflows.

Agendas vary from venue to venue, therefore please click below at the event of interest for the event details.

More dates and cities will be added.

Nov 27, 2018 - Nov 27, 2018
Thermo Fisher Scientific | Stafford House, Boundary Way, Hemel Hempstead, HP2 7GE

Join our pharmaceutical impurity workshop to hear from leaders in the field how you can optimise your impurity analysis workflows to obtain greater productivity, sensitivity, accuracy and reproducibility to meet increasing regulatory requirements and lower limits of detection. Learn how to achieve all of this, whilst also increasing laboratory efficiency and reducing the cost per sample.

Register

Topics

  • Overview of pharmaceutical impurities: Dr. Christian Zeine will present an overview of the topic of pharmaceutical impurities including what constitutes an impurity, the various types of impurities, the regulatory guidelines and detection limits and the important points to consider during impurity testing.
  • Inorganic impurity analysis workflow: During this presentation novel and existing inorganic impurities will be discussed and how ICP-MS can being utilised and optimised to obtain ultimate sensitivity and rapid detection and quantitation of such impurities. Also how automatic method development can improve productivity.
  • Organic impurity analysis workflow: Strategies will be shown to improve productivity, reduce cost per sample and gain deeper insights for organic impurity analysis using novel UHPLC and detector technology. How to achieve confirmation, identification and quantification simultaneously with a multi-detector approach.
  • Ion chromatography for the analysis of pharmaceutical impurities: What are the benefits to using IC-MS compared to standard IC with conductivity? Making mass spectrometry accessible to the chromatographer through chromatography data system (CDS) software.
  • IC/MS applied to impurities in late stage pharmaceutical developmentIC/MS applied to impurities in late stage pharmaceutical development: We will look at the analysis of challenging analytes by IC/MS and its application to pharmaceutical development; particularly organic acids and amines, discussing why this approach may be beneficial over traditional techniques. 
  • Practical session on ibuprofen impurity analysis: Small groups at different stations in the lab (LC station with LC and UV, CAD and MS detection) to investigate impurities in ibuprofen: Rotate around three stations to gain experience of using high-throughput, sensitive and accurate LC-UV, LC-MS, IC-MS and ICP-MS instrumentation to improve performance and productivity in confirmation, identification and quantitation of impurities. Including a demonstration of the efficiency and compliance tools within Thermo Scientific™ Chromeleon™ CDS software to streamline the impurity analysis process.
  • Why use reference standards: This presentation will investigate why to use reference standards and the main points to consider for their use.

 View full agenda ›

For questions about this event please email analyze.eu@thermofisher.com.


Registration 


Participation is free of charge. Registration is required. Lunch is provided.

We are hosting the pharmaceutical impurities workshops in collaboration with  LGC Standards.

More events will be organized over the course of the year.

LGC-Standards-LOGO

Additional Resources

Prior to the workshop, why not take a look at these articles related to pharmaceutical impurities:

  • Introduction to pharmaceutical impurities: An Interview with Dr. Christian Zeine  - Read more
  • Monitoring pharmaceutical impurities - Read more