Skip to main content
. 2021 Feb;62(2):149–155. doi: 10.2967/jnumed.120.260455

TABLE 5.

Final Product Specifications

Test Test method Acceptance criteria
Prerelease
 Radiochemical purity Thin-layer chromatography ≥90%
 Appearance Visual observation Clear solution, free of particulates
 pH pH paper 4.0–7.0
 Endotoxin content PTS Endosafe, USP < 85 > <17.5 EU/mL
 Radiochemical identity Thin layer chromatography* UCLA: Rf value = 0.75–0.95
UCLA: Rf value = 0.3–0.6
 Radionuclidic identity Half-life determination 64.4–71.2 min
 Filter integrity Bubble point pressure reading, USP < 823 > / < 797 > >50 psi
Postrelease
 Sterility Direct inoculation. USP < 71 > / < 823 > Sterile
*

UCLA and UCSF use different mobile phases.