Transcription of VALIDATION OF COMPENDIAL PROCEDURES
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VALIDATION OF COMPENDIAL PROCEDURES
USP 36 General Information / 1225 VALIDATION of COMPENDIAL Procedures1formance characteristics of the procedure meet the require-ments for the intended analytical applications. Typical ana- 1225 VALIDATION OFlytical performance characteristics that should be consideredin the VALIDATION of the types of PROCEDURES described in thisCOMPENDIAL PROCEDURES document are listed in Table 1. Because opinions may differwith respect to terminology and use, each of the perfor-mance characteristics is defined in the next section of thischapter, along with a delineation of a typical method orTest PROCEDURES for assessment of the quality levels ofmethods by which it may be measured. The definitions referpharmaceutical articles are subject to various test results. The description of the analytical procedureAccording to Section 501 of the Federal Food, Drug, andshould define what the test results for the procedure are. AsCosmetic Act, assays and specifications in monographs ofnoted in ISO 5725-1 and 3534-1, a test result is the valuethe United States Pharmacopeia and the National Formularyof a characteristic obtained by carrying out a specified testconstitute legal standards.
2 〈1225〉 Validation of Compendial Procedures / General Information USP 36 PRECISION Analytical Performance Characteristics Definition—The precision of an analytical procedure is
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