Transcript Acceptance Criteria

Radiopharmaceutical Production
Quality Control Testing
Product Stability
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Product Stability
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When the activity concentration of [18F]FDG is
increased to the hundreds of mCi/mL, [18F]fluoride is
the main active product of autoradiolysis and
becomes the most important radiochemical impurity.
The current US Pharmacopeia (USP) stipulates the
minimum radiochemical purity for [18F]FDG as no
less than 90% of the total radioactivity assumed to
be present at the time of administration to a patient.
In contrast, the current European Pharmacopoeia
(EP) stipulates the minimum radiochemical purity for
[18F]FDG and [18F]FDM as no less than 95% of the
total radioactivity of which the [18F]FDM fraction
should not exceed 10% of the total radioactivity.
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Contents
• Acceptance Criteria
• Discussion
• Procedure
Acceptance Criteria
Radiopharmaceutical
Production
QC Testing
Product Stability
Contents
Acceptance Criteria: FDG must comply with the requirement
for parenteral preparations, and must pass the product stability
test. This test needs to be carried out at the highest activity
level and smallest volume that would be expected under normal
production conditions.
Acceptance Criteria
Discussion
Procedure: 200 μL samples of FDG taken within a few minutes
of the end of synthesis should be stored at room temperature
(22 °C) and aliquots (0.1–5 μL as required to offset decay) can
be analysed by radioTLC to monitor the build up of the main
decomposition product (free [18F]fluoride) for up to 14 h post
synthesis.
Procedure
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Discussion
Radiopharmaceutical
Production
QC Testing
Product Stability
Discussion: The product must be validated using this test and
revalidated on a periodic basis or whenever the procedure of
synthesis is changed or there is an increase in yield so that the
activity per unit volume is increased.
Contents
Acceptance Criteria
Discussion
Procedure
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To study the impact of stabilisers, samples of FDG (50–100 μL)
can be treated with reagents to the concentrations shown and
both treated and untreated FDG samples subjected to a room
temperature stability study. Separate stability studies ned to be
performed to observe the effect of (i) radioactive concentration,
(ii) added ethanol, (iii) added hydrogen peroxide, (iv) added
ascorbic acid, (v) added sodium nitrite, (vi) added sodium
thiosulfate and (vii) added sodium iodide upon the
decomposition of FDG.
Stability Procedure
Radiopharmaceutical
Production
QC Testing
Product Stability
Contents
Acceptance Criteria
Discussion
Procedure
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A plot of the amount of fluoride present in the sample should
be generated to show that the purity of the FDG remains with
the acceptance limits during the normal lifetime of the FDG.
Link to Demonstration (UNDER CONSTRUCTION)
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