Prepare Radiopharmaceutical Kits, Perform Quality Control, and Evaluate Resul

Subgroup III: Pharmaceutical and Radiopharmaceutical Agents

aseptic technique

wipe all vials with alcohol, use unopened sterile supplies, PPE

Why should you not inject air into radiopharmaceutical kit vials?

the oxygen will oxidize the stannous ion

exceptions to not injecting air into vial (it’s okay to inject air into these kits)

MAG3, tetrofosmin

maintain ___ pressure in vial

negative

How long can Tc99m eluate be used to make up kits?

6 hours

activity and volume limitations can be found in the ___

package insert

MAA particle size requirements

10-90 um, none larger than 150 um

MAA particle number

200,000-700,000 particles, normal adult target 350,000

reduced MAA particle conditions

pregnancy, pulmonary hypertension, pneumonectomy, pediatrics, right-to-left cardiac shunt

reduced MAA particle number

100,000-250,000 particles

infant MAA particle number

10,000-50,000 particles

when injecting MAA, do NOT

pull back the syringe before injecting

If blood clots in the MAA syringe from pulling back,

the biodistribution will be altered and the exam will not be diagnostic

Just prior to injection, what should you do to MAA syringe?

gently agitate to prevent nonuniform distribution of particles

radiopharmaceutical kit quality control

• visual inspection

• radiochemical putiry

• sterility

• pyrogenicity

visually, radiopharmaceuticals should be

clear, colorless, and free of particulate matter

(exceptions: MAA, colloids, iodine solution)

radiochemical purity

proportion of stated radionuclide that is present in the stated chemical form

radiochemical purity example

free pertechnetate or hydrolyzed reduced pertechnetate after kit makeup

How can you test radiochemical purity?

instant thin layer chromatography

instant thin layer chromatography methodology

put dot of kit prep at origin line of the paper strip; put strip into developing chamber so that bottom (below origin) is in the solvent; allow the solvent to wick up the paper until it reaches the solvent front line

What is usually at the solvent front, Rf = 1.0?

free pertechnetate

What is usually at the solvent origin, Rf = 0.0?

hydrolyzed reduced Tc products

Where will the bound drug be on the ITLC strip?

can localize at either the origin, solvent front, or somewhere in between depending on the drug, solvent, or ITLC strip used

ITLC formula for calculations

% impurity = (net counts in half of strip with impurity) / (total counts on both halves of strip) * 100

How long does sterility testing take?

14 days, cannot be performed prior to patient administration

sterility is tested with

growth of aerobic and anaerobic bacteria in media

pyrogenicity is tested with

bacterial endotoxin test (BET) or limulus amoebocyte lysate (LAL)

labels after kit makeup must include

name of radiopharmaceutical, concentration and/or total activity and volume, assay date and time, expiration date and time

kits that must be refrigerated

MAA, DMSA, Y90 ibritumomab tiuxetan

kits that must be kept from light

MAG3, bicisate, F-18 fluorodopa