Quality control

Which release tests apply to which tracer, and what equipment each test needs. This is mostly a derived list, not a list of monograph requirements: of 303 entries, 15 are confirmed by a pharmacopoeial monograph (Ph. Eur.: 15; USP: 5). The other 288 are derived from the general Ph. Eur. monograph 0125 Radiopharmaceutical preparations and from what the published synthesis states, and 273 of all entries still carry a preliminary mark. Monograph numbers are references only - the texts are copyrighted and are not reproduced. How the derived entries work

Why the USP column is almost empty. USP publishes monographs mainly for drugs approved by the FDA; they are typically developed after approval, at the request of the holder of the application (SNMMI Committee on Pharmacopeia, J Nucl Med 2013). In 2014 USP omitted eight monographs for PET drugs that were not FDA-approved (official 1 December 2014) and stated that it “typically does not maintain monographs for non-FDA approved products”. For a research tracer without FDA approval a USP monograph is therefore not to be expected; for an approved one it may or may not exist, and the USP–NF index is subscription-only, so we could not check. Source: USP, Standards for Radioactive Articles.

Ph. Eur.: a monograph is confirmed for 15 entries and checked as non-existent for 5; 283 are not verified - no check has been recorded for them yet.

USP: a monograph is confirmed for 5 entries; 298 are not verified - the USP–NF index is subscription-only, so this means we could not check, not that no monograph exists.

Rows with an amber edge carry at least one preliminary mark: the test set was inferred from the compound class and isotope, not from a monograph or from what a paper states about the synthesis. Treat those as a starting point for scoping, never as a release specification.