NMTCB PET certification Review UPDATED ACTUAL Questions and CORRECT
Answers
14L of eleute volume reached, or Sr-82 level 0.002uCi/mCi
Rb-82 Genertaor Alert Level
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
17L of eleute volume reached, or 42 days post calibration
Stop using Rb-82 generator if date, or Sr82 levenis 0.01uCi/mCi of Rb82, or Sr85 level
reaches 0.1uCi/mCi of Rb82
C11, 20.3 min; N13 9.97 min; O15 2.03 min; F18, 109.7
Cyclotron produced isotopes and half-life
min
1) less nuclear activation of cyl potion cavity and surround-
Advantages of negative ion cyclotrons ings, 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
Electron rich group of atoms change place on molecule
Chemical reaction of FDG
with a positively charged leaving group
Precursor molecule for FDG Mannose triflate
2-deoxy-2-[18F]fluoro-D-glucose. (Fludeoxyglucose
Chem formula of FDG
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
LAL (Limulus amebocyte lysate) <175 USP endotoxins
FDG QA bacterial endotoxins test
,units per max volume injection;
endotoxins< 17.5 EU
, FDG QC pH Between 4.5 to 7.5
Thin-layered chromatography radioactive Rf should be not
FDG QA Radiochemical purity less than 90% of total radioactivity of chromatography
plate
should be >99.5% of radionuclidie specified. tested using
FDG QC Radionuclideic purity
multi-channel analyzer with peaks at 0.511 and 1.022 MeV
testing depends upon synthesis method used to create
FDG QC chemical purity
FDG
FDG QC chemical purity test - thin-layer paper chromatog-
Kryptofix 222 raphy spot test. 50 ug/mL and FDG solution must demon-
strate a less intense response than standard
FDG QC chemical purity test used if hydrolysis step was
performed with hydrochloric acid. Use high-performance
2-Chloro-2-deoxy-D-glucose liquid chromatography using an electrochemical detector.
Mus not have more than 1 mg CLDG: 2-deoxy-2-D-glu-
cose
solvents can be in FDG from cleaning or synthesis solu-
tions. solutions may contain acetonitrle, ether anddehy-
FDG QC Residual solvents
drated alcohol. no more 0.04% acetonitrle, and less than
0.5% of ether or ethanol
not performed before dosing due to need of 14 days to
perform. Regulations require final produce to be placed
FDG QC Sterility
in soy broth mixture with a thioglycollate growth media for
30 hrs. look for observable bacteria
final sterility filter used at end of manufacturing process.
FDG QC Filter membrane integerity Filter must remain intact as pressure increased to 50 psi
(bubble point test)
room: cGMP, ISO class 5 clean room air hood, 21 CFR 212
FDG synthesis room requirements
for manufacturing of IV drugs
Answers
14L of eleute volume reached, or Sr-82 level 0.002uCi/mCi
Rb-82 Genertaor Alert Level
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
17L of eleute volume reached, or 42 days post calibration
Stop using Rb-82 generator if date, or Sr82 levenis 0.01uCi/mCi of Rb82, or Sr85 level
reaches 0.1uCi/mCi of Rb82
C11, 20.3 min; N13 9.97 min; O15 2.03 min; F18, 109.7
Cyclotron produced isotopes and half-life
min
1) less nuclear activation of cyl potion cavity and surround-
Advantages of negative ion cyclotrons ings, 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
Electron rich group of atoms change place on molecule
Chemical reaction of FDG
with a positively charged leaving group
Precursor molecule for FDG Mannose triflate
2-deoxy-2-[18F]fluoro-D-glucose. (Fludeoxyglucose
Chem formula of FDG
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
LAL (Limulus amebocyte lysate) <175 USP endotoxins
FDG QA bacterial endotoxins test
,units per max volume injection;
endotoxins< 17.5 EU
, FDG QC pH Between 4.5 to 7.5
Thin-layered chromatography radioactive Rf should be not
FDG QA Radiochemical purity less than 90% of total radioactivity of chromatography
plate
should be >99.5% of radionuclidie specified. tested using
FDG QC Radionuclideic purity
multi-channel analyzer with peaks at 0.511 and 1.022 MeV
testing depends upon synthesis method used to create
FDG QC chemical purity
FDG
FDG QC chemical purity test - thin-layer paper chromatog-
Kryptofix 222 raphy spot test. 50 ug/mL and FDG solution must demon-
strate a less intense response than standard
FDG QC chemical purity test used if hydrolysis step was
performed with hydrochloric acid. Use high-performance
2-Chloro-2-deoxy-D-glucose liquid chromatography using an electrochemical detector.
Mus not have more than 1 mg CLDG: 2-deoxy-2-D-glu-
cose
solvents can be in FDG from cleaning or synthesis solu-
tions. solutions may contain acetonitrle, ether anddehy-
FDG QC Residual solvents
drated alcohol. no more 0.04% acetonitrle, and less than
0.5% of ether or ethanol
not performed before dosing due to need of 14 days to
perform. Regulations require final produce to be placed
FDG QC Sterility
in soy broth mixture with a thioglycollate growth media for
30 hrs. look for observable bacteria
final sterility filter used at end of manufacturing process.
FDG QC Filter membrane integerity Filter must remain intact as pressure increased to 50 psi
(bubble point test)
room: cGMP, ISO class 5 clean room air hood, 21 CFR 212
FDG synthesis room requirements
for manufacturing of IV drugs
