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NMTCB PET CERTIFICATION REVIEW QUESTIONS WITH CORRECT ANSWERS GRADED A

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NMTCB PET CERTIFICATION REVIEW 2023 - 2024 QUESTIONS WITH CORRECT ANSWERS GRADED A NMTCB PET CERTIFICATION REVIEW 2023 - 2024 QUESTIONS WITH CORRECT ANSWERS GRADED A NMTCB PET CERTIFICATION REVIEW 2023 - 2024 QUESTIONS WITH CORRECT ANSWERS GRADED A NMTCB PET CERTIFICATION REVIEW 2023 - ...

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  • February 4, 2024
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NMTCB PET CERTIFICATION REVIEW 2023 -
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

,NMTCB PET CERTIFICATION REVIEW 2023 -
2024 QUESTIONS WITH CORRECT ANSWERS
GRADED A

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

,NMTCB PET CERTIFICATION REVIEW 2023 -
2024 QUESTIONS WITH CORRECT ANSWERS
GRADED A
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

, NMTCB PET CERTIFICATION REVIEW 2023 -
2024 QUESTIONS WITH CORRECT ANSWERS
GRADED A
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

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