Recommendations for titration methods validation
WP-068
en
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.
Manual titration is one of the oldest analytical procedures. A transfer from manual titration to automated titration can make validation necessary. This White Paper, developed in collaboration with the U.S. Pharmacopeia (USP), offers guidance for validating titration methods in accordance with USP <1225> and ICH Guidance Q2(R1) requirements.
Key topics covered in this White Paper are:
- Validation parameters: method validation for titration should include determination of the specificity, linearity, accuracy, and precision. This is necessary to obtain a complete picture of the suitability of the method for the analysis of the analyte of interest.
- Real-world example: the validation process is demonstrated for the assay of potassium bicarbonate by titration with hydrochloric acid.
Download our white paper
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.