השוואת שיטות

	תוקף לשיטה אנליטית	כרומטוגרפיית יונים
תחום	כימיה אנליטית	כימיה אנליטית
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1995	1975
הוגה השיטה	FDA and ICH regulatory agencies	Hamish Small
סוג	regulatory and quality control framework	separation and analysis technique
מקור מכונן	Food and Drug Administration. (2015). Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. FDA Guidance for Industry.	Small, H., Stevens, T. S., & Bauman, W. C. (1989). Novel ion exchange chromatographic method using conductometric detection. Analytical Chemistry, 47(11), 1801–1809.
כינויים	method validation, analytical validation, OOS investigation, protocol validation	IC, ion-exchange chromatography, IEC
קשורות	5	5
תקציר	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).	Ion chromatography is a liquid chromatography method that separates ions and polar molecules based on their relative affinity for the ion exchange resin in the column. Developed by Hamish Small in 1975, it combines ion-exchange separation with conductivity detection, enabling rapid, sensitive, and simultaneous determination of multiple ions in a single analysis. Ion chromatography has become an indispensable tool for monitoring environmental pollutants, analyzing food and pharmaceutical products, and studying complex ionic mixtures.