Limit of Common or Small Nitrosamine Impurities in RSM irrespective of any particular MDD

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This previous discussion should be able to help you understand regulatory expectations for the method validation parameters…

Analytical procedure development and proposed established conditions: A case study of a mass spectrometry based NDSRI analytical procedure -Pub

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> [image] The publication is open-access, so it is a must-read by any community member involved in confirmatory testing. @trust_user_a @Nitrosamines_Analyzer @trust_user_c @trust_user_d