TABLE 5

Final Product Specifications

TestTest methodAcceptance criteria
Prerelease
 Radiochemical purityThin-layer chromatography≥90%
 AppearanceVisual observationClear solution, free of particulates
 pHpH paper4.0–7.0
 Endotoxin contentPTS Endosafe, USP < 85 ><17.5 EU/mL
 Radiochemical identityThin layer chromatography*UCLA: Rf value = 0.75–0.95
UCLA: Rf value = 0.3–0.6
 Radionuclidic identityHalf-life determination64.4–71.2 min
 Filter integrityBubble point pressure reading, USP < 823 > / < 797 >>50 psi
Postrelease
 SterilityDirect inoculation. USP < 71 > / < 823 >Sterile
  • * UCLA and UCSF use different mobile phases.