Analytical laboratory methods developed and used by FDA to test certai

Listed below are analytical laboratory methods developed and used by FDA to test certain drug quality attributes that also may impact safety. These FDA testing methods are intended to detect impurities in certain drug substances and certain drug products. For information on submitting these or any other analytical laboratory methods and methods validation data to support new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) , please refer to the guidance Analytical Procedures and Methods Validation for Drugs and Biologics (July 2015).