[Question] Ireland — has anyone got a straight answer on method development
gradient. That is the whole post, but I will justify it. Everything else people worry about in c/reconstitution is downstream of it. Titration speed, reflux, the endless dose arguments — most of it resolves if you sort gradient out first, and almost nobody does. I say this having got it wrong for 6 months. My fasting…
Yeah, the chromatogram profile matters more than the headline number.
The related substances profile is way more interesting than the main peak %. A 98% with 21 peaks is different from a 98% that is one 37% impurity.
The related substances profile is way more interesting than the main peak %.
Disagree on that part. 99.2% and 99.3% on the same vial is normal.
Detection wavelength? LC-MS and that changes at different wavelengths.
state the method: column, gradient, detection wavelength, injection volume
Tracking number removed. It identifies both ends of a shipment.