White Paper gives guidance for validation of titration methods

Pharmaceutical assay determination as per USP methods

Using validated methods is a must for pharmaceutical assay determination to comply with regulatory requirements. A free white paper gives guidance and defines a procedure how to perform a proper validation of titration methods. The procedure follows ICH Guidance Q2(R1) and USP General Chapter <1225> and is exemplified using the determination of potassium bicarbonate sample as an example.

Method validation of a titration ensures that the selected titration method and parameters provide a reliable and robust result. The procedure outlined in our white paper defines and describes the following steps and criteria:

  • Titrant standardization
  • Specificity, i.e. the ability to assess the analyte
  • Linearity of the analytical procedure (defined as the linear regression of the sample size versus the consumed titrant volume)
  • Accuracy (defined as the closeness of the result to the true value)
  • Precision (defined as standard deviation and evaluated in two levels: repeatability and intermediate precision)

The procedure is exemplified using a potassium bicarbonate sample.

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WP 068: Recommendations for titration methods validation