Simultaneous analytical method [Bioanalytics]

posted by Obinoscopy  – USA, 2018-09-12 11:35 (1840 d 00:52 ago) – Posting: # 19268
Views: 3,548

Dear Giang

❝ It's a bioanalytical method for determination of 5 anti-TB drugs by LC-MS/MS. One just raise the question: Can we apply this method for just 2/3 APIs? Is there any infuence or differences? Do we need to revalidate the method, partial or full, and which criteria? Many thanks!

I don't think you need to revalidate as long as the 2/3 APIs were among the 5 APIs that were validated.

But if I may ask, did you include all the CCs and QCs for the entire 5 APIs in the same analytical run?


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