or better than, the USP method, if you are not using current USP compendial methods. Include all findings and deviations encountered in assessing whether your alternative method is equivalent or superior to the USP compendial method. For FDA’s current ...
A comprehensive study that determines whether your test methods for your API are equivalent to, or better than, the USP method, if you are not using current USP compendial methods. Include all findings and deviations encountered in assessing whether your alternative method is equivalent or superior ...
A validated alternative analytical procedure should be submitted only if it is shown to perform. equal to or better than the regulatory analytical procedure.B. 替代分析方法替代分析方法是申请者提出用于代替法定分析方法的分析方法。只有当一替代分析方法相当于或优于法定分析方法时,才可以应用验证过的替代...
any applicant choosing to develop an alternative method should beaware that test methods can be complicated by the fact that BCC are highlyadaptable and variable in their ability to survive
oxygen manufacturing process even though the USP does not listhydrocarbons as an impurity. Also, alternative methods may be needed to testhigh-pressurecylinders for cleaning solution residues. 不能。虽然顺磁和激光氧分析仪在正确校正的情况下是非常准确可靠的,但这类分析仪只能鉴别以及检出氧含量,而不能检...
The U.S. Food and Drug Administration (FDA) is committed to facilitating the development, validation, and regulatory acceptance of new toxicological testing methods. Moreover, there is strong support to actively challenge the international science community to discover methods more predictive of human ...
ResidualSolvents467:MainPoints,Continued…“Theproceduresdescribedinthisgeneralchapteraretobeappliedwhereverpossible.Otherwise,manufacturesmayselectthemostappropriatevalidatedanalyticalprocedureforaparticularapplication.”(ICHandEPtakesimilarapproach,see1225ValidationofCompendialProceduresSubmissionofalternativemethodsisnotrequired...
Sampling should include swabbing, rinsing, or alternative methods (., direct extraction), as appropriate, to detect both insoluble and soluble residues. The sampling methods used should be capable of quantitatively measuring levels of residues remaining on the equipment surfaces after cleaning. Swab ...
Your commitment to using current USP compendial methods until any alternative methods have been demonstrated to be equivalent or better than the USP methods. 你们的承诺:使用现行 USP药典方法,直到任何替代方法已被证明等效的或优于 USP 方法。
Alternative methods and controls and variations in methods and controls within reasonable limits that do not affect the characteristics of the substance or the reliability of the controls may be specified. If the food additive is a mixture of chemicals, the petition shall supply a list of all ...