方法对比

	分析方法验证	紫外-可见分光光度法
领域	分析化学	分析化学
方法族	Process / pipeline	Process / pipeline
起源年份	1995	1852
提出者	FDA and ICH regulatory agencies	August Beer
类型	regulatory and quality control framework	absorption measurement technique
开创性文献	Food and Drug Administration. (2015). Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. FDA Guidance for Industry.	Beer, A. (1852). Bestimmung der Absorption des rothen Lichts in farbigen Flussigkeiten. Annalen der Physik und Chemie, 86(5), 78–88.
别名	method validation, analytical validation, OOS investigation, protocol validation	UV-Vis spectroscopy, absorption spectroscopy, colorimetry
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).	UV-Vis spectrophotometry is an optical analytical technique that measures the absorption of ultraviolet and visible light (wavelengths 190–900 nm) by substances in solution. Founded on the Beer-Lambert law (developed by August Beer and Pierre Bouguer), it is one of the oldest and most widely used quantitative analytical methods. UV-Vis spectrophotometry is economical, rapid, and applicable to a vast range of organic and inorganic compounds, making it indispensable in pharmaceutical, clinical, environmental, and research laboratories.