Residual solvents: regulatory requirements, method development and validation

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Residual solvents are controlled in pharmaceutical excipients and dosage forms according to different classifications and limits. This course will explain the way in which residual solvent specification limits are derived and introduce delegates to strategies for method development and validation.

Residual solvents – a definition

Residual solvent classifications and specification limits

  • Calculation of Class 2 limits according to ICH Option 1 and Option 2
  • Worked examples

Techniques for residual solvent analysis

  • Headspace and SPME sample introduction
  • Techniques for solute focusing post-injection
  • Compendial methods

Method development

  • Sample preparation tips & tricks
  • Optimisation of method conditions

           * GC

           * Headspace

           * SPME

Method validation

  • Setting acceptance criteria with reference to drug product specifications
  • Quantitative method vs. limit test ” pros and cons
  • Specificity
  • Sensitivity (limits of detection and quantitation)
  • Linearity/range
  • Accuracy/recovery
  • Precision
  • Robustness
  • Solution stability

Mark Powell - Analytical Services (Dissolution Testing, QbD, HPLC)

Mark Powell - Analytical Services (Dissolution Testing, QbD, HPLC)

Mark is a Fellow of the Royal Society of Chemistry with over thirty years' experience as a senior analytical chemist. He taught pharmaceutical analysis at the Liverpool John Moores University School of Pharmacy and Chemistry from 1997 to 2003 and was also active in research.

In 2003, he joined the newly-formed Quay Pharmaceuticals, a contract research and manufacturing organisation specialising in early-stage drug development, where he was responsible

for analytical development. Since 2010, as Quay"s Scientific Manager, Mark was involved more generally with drug development programmes and also established collaborations with a number of UK universities and instrument manufacturers. His work at Quay has resulted in a number of published papers and presentations at scientific conferences.

In 2013 Mark set up his own consultancy company and has since worked

for clients all over the world on both early-stage and late-stage drug

development projects. He has particular expertise in dissolution method development and chromatography, and is in demand as a trainer in topics ranging from pharmaceutical analysis to data integrity and technical report writing.

This course is aimed at personnel who need to understand the regulatory requirements concerning residual solvents and those engaged in method development and validation.


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