Pharmaceutical impurity characterisation – strategies for success

Hosted by RSSL's Daniel Nicolau and Cathy Frankis, this webinar considers the analytical techniques that can be applied for the assessment and characterisation of impurities.

 

 

The need to identify and characterise unknown impurities in pharmaceutical products is of paramount importance. Characterisation is required to allow for toxicological assessment of degradation products and allows greater understanding of degradation pathways which may influence the efficacy of the treatment.

 

A wide range of analytical techniques may be called upon during characterisation studies, depending on the nature and size of the impurity molecule, the complexity of the formulation matrix and the level at which the impurity is observed. 

 

This webinar will take a deep dive into nuclear magnetic resonance (NMR) spectroscopy and accurate mass liquid chromatography mass spectrometry (LC-MS) to leverage knowledge in the assessment and characterisation of this industry critical scientific challenge.

Topic areas we cover include:
  • Understanding impurities - contamination in a nutshell
  • Recognising the scientific necessity and regulatory requirements
  • Appreciating the analytical tools typically used, including their advantages and limitations
  • Understanding the approach to characterising impurities with attention given to LC-MS and NMR

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About the Speakers

 

Catherine Frankis is a senior scientist working across the functional ingredients and investigative analysis teams. Catherine has worked on a wide variety of projects, including the development and validation of new analytical methods within the food, pharmaceutical and cosmetic industries.

 

 

Daniel Nicolau has taken a leading role in the delivery of RSSL's LC-MS techniques and our nitrosamines testing service. A technical specialist in key analytical fields, Daniel's chemical knowledge, resourcefulness and expertise enables him to assist clients with their regulatory submissions and troubleshooting needs.

 

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