Judge a method against its intended purpose and validation evidence.
Define the intended measurement
Identity, assay and impurity analysis are different tasks. ICH Q2(R2) addresses validation characteristics such as specificity/selectivity, range, accuracy and precision in relation to intended use. A method name should be read together with its sample and analytical purpose.
Sources [1]
The technique name does not define the validated scope
“RP-HPLC” names a technique, not its demonstrated separation capability or scope. Applying a procedure to another substance, matrix or reporting purpose requires assessing coverage of the evidence. Q14 provides scientific and risk-based development principles rather than judging validity from a molecule’s name alone.
Sources [2]
Read each analytical file on its own terms
For semaglutide and tirzepatide, record each analytical purpose, method version, reference standard and validated scope before comparing results. A shared procedure may be justified by suitable evidence. Sharing only a technique name or a purity statement does not supply that evidence.
Original sources
These notes explain public references; they do not replace sample-specific testing or case-specific professional judgment.