手法を比較

	分析法バリデーション	クーロメトリー
分野	分析化学	分析化学
系統	Process / pipeline	Process / pipeline
提唱年	1995	1945
提唱者	FDA and ICH regulatory agencies	James Lingane
種類	regulatory and quality control framework	electrochemical titration
原典	Food and Drug Administration. (2015). Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. FDA Guidance for Industry.	Lingane, J. J. (1974). Electroanalytical Chemistry (2nd ed.). Interscience Publishers. ISBN: 978-0486409023
別名	method validation, analytical validation, OOS investigation, protocol validation	coulometric titration, electrochemical coulometry, amperes titration
関連	5	5
概要	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).	Coulometry is an electrochemical analytical method that determines the concentration of an analyte by measuring the total electric charge (in coulombs) required to oxidize or reduce the analyte completely at an electrode. Developed by James J. Lingane in the 1940s, coulometry is highly accurate because it is based on fundamental constants (Faraday's law) and does not require external standards or calibration curves. This method is particularly valuable for trace analysis, water determination, and analysis of reactive species.