Radiopharmaceutical Stability Studies Of Fdg And Naf When Dispensed In A Unit Dose Syringe: Application To Commercial Distribution And In-House Pet Imaging Center Studies During Normal Working Hours

1078 Objectives: The purpose was to evaluate the stability of Fludeoxyglucose F 18 Injection (FDG) and Sodium Fluoride (NaF) residing in a syringe over the entire expiration time frame, including the potential temperature excursion that may occur during shipment of the unit dose syringe. Each batch was prepared targeting a radioactive concentration at end of synthesis (EOS) of approximately 150-220 mCi/mL. An 8mL drug product sample in a syringe would then be approximately 1200 mCi or a 12.75 mCi patient dose at 12 hours EOS. It was the intent of this study to assess the stability of the drug product in a typical patient dose at near or above the maximum radioactive concentration at maximum dose volume. These parameters embody the greatest syringe surface area contact and worst case scenarios for the stability indicating tests. Some State Boards of Pharmacies require documented evidence to prove equivalency when a drug is transferred from one container to another.\n Methods: The stability of each drug was assessed on a total of 9 syringes (3 different manufacturer syringes in triplicate) filled with 8 mL of drug product and stored at 20-25 oC, and 9 syringes filled with 8 mL of drug product and stored at 45-55 oC. Quality control testing of the final product vial was conducted at EOS. Each syringe was stored with drug product at controlled room temperature (CRT) or in an incubator/oven at 45-55 oC where no light could enter for at least 12 hours. Stability indicating tests were performed at least 12 hours post-EOS. Each batch was analyzed for long lived radionuclides (radionuclidic purity)\n Results: Conclusions: These results demonstrate the stability of the FDG and NaF formulation in each of the three manufacturer syringes filled with 8mL of drug product at specific concentrations of 150- 220 mCi/mL over a period of 12 hours stored at CRT and between 45-55°C. The quality of the drug product at EOS produced in a glass vial is equivalent to the quality of the maximum amount of drug product residing in the three different manufacturer syringes. This equivalency in quality of the drug product stored in the specified syringes at the specified temperatures over 12+hours demonstrates that the drug product is stable in the specified syringes throughout the expiry of the drug product.