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Standardization For method validation in titration, titrant standardization is the first step to obtaining the most reliable results. Dilution and weighing 2 〈〉 Validation of Compendial Procedures General Information USPPRECISION Analytical Performance Characteristics Definition—The precision of an 〈〉 Validation of Compendial Procedures Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 2 〈〉 Validation of Compendial Procedures General Information USPPRECISION Analytical Performance Characteristics Definition—The precision of an analytical procedure is the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of ACCURACY a homogeneous sample 〈〉 Validation of Compendial Procedures Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. It also gives examples of titration This chapter provides information on acceptable practices for the analysis and interpretation of data obtained from chemical and other analyses. It covers basic statistical , which was first published in USP XXI (), served as the foundation for the development of the ICH Q2 Guidance on Validation of Analytical Procedures (1). More VALIDATION OF COMPENDIAL METHODS. According to A paper that provides recommendations for the validation of titration methods, including standardization, specificity, linearity, and precision. Test procedures for assessment of the quality levels of pharmaceutical products are subject to various requirements. According to Section of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the USP–NF constitute legal standards Methodology (1) and in USP General Chapter > Validation of Compendial Procedures (2). The objective of this paper is to provide some recommendations for the validation of titration methods.