方法对比

	分析方法验证	原子吸收光谱法
领域	分析化学	分析化学
方法族	Process / pipeline	Process / pipeline
起源年份	1995	1955
提出者	FDA and ICH regulatory agencies	Alan Walsh
类型	regulatory and quality control framework	elemental analysis 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.	Walsh, A. (1955). The application of atomic absorption spectra to chemical analysis. Spectrochimica Acta, 7, 108–117.
别名	method validation, analytical validation, OOS investigation, protocol validation	AAS, flame AAS, graphite furnace AAS, GFAAS
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).	Atomic absorption spectroscopy is an analytical technique that measures the concentration of metal elements by detecting the absorption of light by ground-state metal atoms in the gaseous state. Invented by Alan Walsh in 1955, it rapidly became the standard method for trace metal analysis in environmental, clinical, agricultural, and industrial samples. Atomic absorption spectroscopy's sensitivity, selectivity, and simplicity make it indispensable for monitoring toxic metals, nutritional minerals, and elements in complex matrices.