Residual solvents: regulatory requirements, method development and validation

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Overview

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.

Who Should Attend?

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

Course Programme

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
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