NMTCB PET certification Review

NMTCB PET certification Review questions with correct answers GRADED A Rb-82 Genertaor Alert Level - 14L of eleute volume reached, or Sr-82 level 0.002uCi/mCi of Rb-82, or Sr-85 level 0.02uCi/mCi of Rb-82 Actions for Rb82 Generator Alert Level - Test after every 750 mL has passed through generator Stop using Rb-82 generator if - 17L of eleute volume reached, or 42 days post calibration date, or Sr82 levenis 0.01uCi/mCi of Rb82, or Sr85 level reaches 0.1uCi/mCi of Rb82 Cyclotron produced isotopes and half-life - C11, 20.3 min; N13 9.97 min; O15 2.03 min; F18, 109.7 min Advantages of negative ion cyclotrons - 1) less nuclear activation of cyl potion cavity and surroundings, 2) can self-focus beam of particles, 3) can irradiate 2 targets at once Isotopes produces by negative ion cyclotrons - C, N, O = metabolites Reaction for chemical labeling of F18-FDG - Nucleophilic substitution Chemical reaction of FDG - Electron rich group of atoms change place on molecule with a positively charged leaving group Precursor molecule for FDG - Mannose triflate Chem formula of FDG - 2-deoxy-2-[18F]fluoro-D-glucose. (Fludeoxyglucose F-18) Intermediate step in FDG synthesis - Alkaline hydrolysis of 4 acetyl groups by replacing with OH Size filter used after purification - 0.22 um FDA ref for PET pharma production - General chapter 823 FDG QA appearance - Colorless liquid FDG QA radiochemical identity - Thin-layer chromatography Rf value to reference standard FDG QARadionuclide identity - Half-life 105 and 115 minutes FDG QA bacterial endotoxins test - LAL (Limulus amebocyte lysate) 175 USP endotoxins units per max volume injection; endotoxins 17.5 EU FDG QC pH - Between 4.5 to 7.5 FDG QA Radiochemical purity - Thin-layered chromatography radioactive Rf should be not less than 90% of total radioactivity of chromatography plate FDG QC Radionuclideic purity - should be 99.5% of radionuclidie specified. tested using multichannel analyzer with peaks at 0.511 and 1.022 MeV FDG QC chemical purity - testing depends upon synthesis method used to create FDG Kryptofix 222 - FDG QC chemical purity test - thin-layer paper chromatography spot test. 50 ug/mL and FDG solution must demonstrate a less intense response than standard 2-Chloro-2-deoxy-D-glucose - FDG QC chemical purity test used if hydrolysis step was performed with hydrochloric acid. Use high-performance liquid chromatography using an electrochemical detector. Mus not have more than 1 mg CLDG: 2-deoxy-2-D-glucose FDG QC Residual solvents - solvents can be in FDG from cleaning or synthesis solutions. solutions may contain acetonitrle, ether anddehydrated alcohol. no more 0.04% acetonitrle, and less than 0.5% of ether or ethanol FDG QC Sterility - not performed before dosing due to need of 14 days to perform. Regulations require final produce to be placed in soy broth mixture with a thioglycollate growth media for 30 hrs. look for observable bacteria FDG QC Filter membrane integerity - final sterility filter used at end of manufacturing process. Filter must remain intact as pressure increased to 50 psi (bubble point test) FDG synthesis room requirements - room: cGMP, ISO class 5 clean room air hood, 21 CFR 212 for manufacturing of IV drugs which radiouclides are possible radioactive contaminates in eluent of Rb82 generators - Sr82 and Dr85 negative ion PET cyclotrons accelerate which partiles - negatively charged hydrogen atoms chemical method used to label F18 to glucose - nucleophilic substitution