NMTCB PET certification Review2023-2024 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 multi-
channel 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
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 multi-
channel 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
