方法对比

	分析方法验证	电位滴定法
领域	分析化学	分析化学
方法族	Process / pipeline	Process / pipeline
起源年份	1995	1909
提出者	FDA and ICH regulatory agencies	Soren Sorensen
类型	regulatory and quality control framework	titration method
开创性文献	Food and Drug Administration. (2015). Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. FDA Guidance for Industry.	Skoog, D. A., West, D. M., Holler, F. J., & Crouch, S. R. (2014). Fundamentals of Analytical Chemistry (9th ed.). Cengage Learning. ISBN: 978-1133170960
别名	method validation, analytical validation, OOS investigation, protocol validation	potentiometry, electrochemical titration
相关	5	5
摘要	Analytical method validation is a systematic process of establishing documented evidence that an analytical method is suitable for its intended use in measuring the identity, purity, strength, and/or content of a substance. Governed by regulatory agencies (FDA, ICH) and industry standards (USP, EP), validation ensures that analytical methods are reliable, accurate, and suitable for quality control in pharmaceutical, food, chemical, and environmental industries. Method validation is mandatory for regulatory submissions and is a cornerstone of good manufacturing practice (GMP).	Potentiometric titration is an electrochemical method of analysis that measures the potential difference between a reference electrode and an indicator electrode as a titrant is gradually added to a solution. Developed in the early 20th century, it allows precise determination of the concentration of analytes without requiring visual endpoint indicators. This method is fundamental in analytical chemistry for determining acids, bases, redox species, and metal ions.