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Pengesahan Kaedah Analitik×Spektroskopi Serapan Atom×
BidangKimia AnalisisKimia Analisis
KeluargaProcess / pipelineProcess / pipeline
Tahun asal19951955
PengasasFDA and ICH regulatory agenciesAlan Walsh
Jenisregulatory and quality control frameworkelemental analysis technique
Sumber perintisFood and Drug Administration. (2015). Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. FDA Guidance for Industry. link ↗Walsh, A. (1955). The application of atomic absorption spectra to chemical analysis. Spectrochimica Acta, 7, 108–117. DOI ↗
Aliasmethod validation, analytical validation, OOS investigation, protocol validationAAS, flame AAS, graphite furnace AAS, GFAAS
Berkaitan55
RingkasanAnalytical 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.
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ScholarGateBandingkan kaedah: Analytical Method Validation · Atomic Absorption Spectroscopy. Dicapai 2026-06-17 daripada https://scholargate.app/ms/compare