滴定方法验证的专业建议
WP-068
zh
分析方法验证旨在证明其适用于预期用途。有关方法验证的建议可参考ICH指导原则Q2(R1)《分析程序验证：文本与方法学》及美国药典通则<1225>《药典程序验证》。本技术白皮书旨在为滴定方法的验证工作提供专业性指导建议。
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.