Hi everyone,
Can anybody share me the reference for acceptance criteria for method validation of Nitrosamines method. For example, what should be % RSD criteria in system suitability standards if the standard has a concentration of 10ppb? Similarly what should be the criteria for repeatability, accuracy, intermediate precision and linearity criteria for method validation?
Hello,
these could be useful sources:
USP chapter on mass spectrometry <736>
paper: Analytical Procedure Development and Proposed Established Conditions: A Case Study of a Mass Spectrometry Based NDSRI Analytical Procedure - ScienceDirect
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you may also refer - if you havent already- to 2.3.1. Analytical Methods
Nitrosamines EMEA-H-A5(3)-1490 - Assessment Report
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Hola buen día.
Te comparto el enlace de publicación en donde el Master @Yosukemino comparte su articulo referente al desarrollo de metodologia por espectrometria de masas.
De igual manera te comparto la información que comparte el master @Naiffer_Host referente a los criterios de aceptación.
Saludos.
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