Accepted answer
Gradient slope is the most powerful parameter and almost nobody mentions it, which is why two reports on the same material disagree by a point.
Tailing factor measures peak shape, and a badly tailing peak spreads into the region where small impurities live, forcing tangent-skim integration that assigns tail area to the main peak.
Put another way, buffer versus acid in the mobile phase changes the ionisation state of basic and acidic residues, shifting retention and selectivity — same vial, potentially different separation.
The ICH Q3A impurity thresholds and the relevant pharmacopoeial chapters all specify method validation requirements that almost no research-grade certificate claims to meet.
If you are ranking vendors, specify a method and have all samples tested at the same place.
7I would add a sentence about sterility here, since it is the thing people skip. – a_lindgren 3 months ago 6The placebo-arm figure is the part everyone omits. – RP_C18 2 months ago add a comment