Сравнение на методи

	Валидиране на аналитичен метод	Потенциометрично титруване
Област	Аналитична химия	Аналитична химия
Семейство	Process / pipeline	Process / pipeline
Година на възникване	1995	1909
Създател	FDA and ICH regulatory agencies	Soren Sorensen
Тип	regulatory and quality control framework	titration method
Основополагащ източник	Food and Drug Administration. (2015). Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. FDA Guidance for Industry.	Skoog, D. A., West, D. M., Holler, F. J., & Crouch, S. R. (2014). Fundamentals of Analytical Chemistry (9th ed.). Cengage Learning. ISBN: 978-1133170960
Други названия	method validation, analytical validation, OOS investigation, protocol validation	potentiometry, electrochemical titration
Свързани	5	5
Резюме	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).	Potentiometric titration is an electrochemical method of analysis that measures the potential difference between a reference electrode and an indicator electrode as a titrant is gradually added to a solution. Developed in the early 20th century, it allows precise determination of the concentration of analytes without requiring visual endpoint indicators. This method is fundamental in analytical chemistry for determining acids, bases, redox species, and metal ions.