WP-068
Recommendations for titration methods validation
Summary
The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. Recommendations for the validation of analytical methods can be found in ICH Guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology and in USP General Chapter <1225> Validation of Compendial Procedures. The goal of this white paper is to provide some recommendations for the validation of titration methods.
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Method validation of a titration ensures that the selected titration method and parameters provide a reliable and robust result. This white paper gives guidance on titration methods validation, discussing titrant standardization, specificity, and much more.