I don't think implying all aggregates and bigger than 0.22 um is anywhere near true.
This is extreme falsehood.
Could you point me to, for example, somatropin monograph requiring so?
LCMS is basically unheard of in pharmacopeia. Bioassay is used exactly once in qualifying the product and particle analysis is not conducted in any manner other than dimer and aggregate analysis of *filtered* preparation. As far as I can tell.
Thank you.
