Hola buen día.@Yosukemino comparte su articulo referente al desarrollo de metodologia por espectrometria de masas.
Dr. Jinhui Zhang et. al from FDA published a new article about A case study of a mass spectrometry based NDSRI analytical procedure.
https://jpharmsci.org/article/S0022-3549(24)00266-1/abstract#%20
Abstract
With the finalization of the ICH Q14 Analytical Procedure Development guideline, how to apply enhanced approaches (such as analytical quality by design (AQbD)) to develop an analytical procedure, and to propose Established Conditions (ECs) and corresponding reporting categories, is increas…
De igual manera te comparto la información que comparte el master @Naiffer_Host referente a los criterios de aceptación.
Community members, greetings!
I frequently get asked about the analytical attributes a nitrosamine testing method should carry… This week’s publication from FDA is a fantastic case on the exceptional use of ICHQ14, ICH Q2(R2), and USP <1220>
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The publication is open-access, so it is a must-read by any community member involved in confirmatory testing.
@trust_user_a @trust_level_1 @trust_user_c @trust_user_d
Saludos.
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