Sodium Fluoride F18Injection
»Sodium Fluoride F18Injection is a sterile solution,suitable for intravenous administration,of sodium fluoride in Sodium Chloride Injection in which a portion of the molecules are labeled with radioactive 18F(see Radiopharmaceuticals for Positron Emission Tomography—Compounding á823ñ).It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 18Fexpressed in megabecquerels (or in millicuries)per mLat the time indicated in the labeling.
Specific activity: no carrier added.
Packaging and storage— Preserve in single-dose or multiple-dose containers that are adequately shielded.
Labeling— Label container to include the following,in addition to the information specified for Labelingunder Injections á1ñ:the time and date of calibration;the amount of 18Fas fluoride anion expressed as MBq (or mCi)per mL,at time of calibration;total activity at time of calibration;the expiration time and date;and the statements “Caution—Radioactive Material”and “Do not use if cloudy or if it contains particulate matter.”Label it to indicate that the radioactive half-life of 18Fis 109.7minutes,and that in making dosage calculations,correction is to be made for radioactive decay.
Radionuclide identification (see Radioactivity á821ñ)—
A: Its half-life,determined using a suitable detector system,is between 105and 115minutes.
B: Radiochemical identity—The retention time of the major peak in the chromatogram of the Test solutioncorresponds to that in the chromatogram of the Standard solution,as obtained in the test for Radiochemical purity.
Bacterial endotoxins á85ñ— It contains not more than 175/VUSP Endotoxin Unit per mLof the Injection,in which Vis the maximum administered total dose,in mL,at the expiration time.It also meets the requirements of Quality Controlunder Radiopharmaceuticals for Positron Emission Tomography—Compounding á823ñ.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 4.5and 8.0.
Chemical purity— This article may be synthesized by different methods and processes and may,therefore,may contain different impurities.The presence of unlabeled ingredients,reagents,and by-products specific to the process must be controlled,and their potential for physiological or pharmacological effects must be considered.
Radiochemical purity—
Mobile phase— Prepare a filtered and degassed solution of 0.003Nsulfuric acid in water.
Standard solution— Dissolve an accurately weighed quantity of USP Sodium Fluoride RSin water,and dilute quantitatively,and stepwise if necessary,with water to obtain a solution having a known concentration of about 0.1mg per mL.
Test solution— Use the Injection.
Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a flow-through gamma ray detector,a conductivity detector,and a 7.5-mm ×30-cm column that contains 10-µm packing L17.The flow rate is about 0.8mLper minute.Chromatograph the Test solution,and record the peak responses as directed for Procedure:the relative standard deviation for replicate injections is not more than 5%.
Procedure— Prepare a solution of the Test solutionand the Standard solution,inject about 50µLof the combined solution into the chromatograph,record the chromatograms,and measure the areas for both the radioactive and nonradioactive peaks (the injection volume may be adjusted to obtain suitable detection system sensitivity):the radioactivity of the major peak is not less than 95%of the total radioactivity measured;and the retention time of the Test solutioncorresponds to the retention time (about 8minutes)of the Standard solution.
Radionuclide purity— Using a suitable gamma-ray spectrometer (see Selection of a Counting Assemblyunder Radioactivity á821ñ),count an appropriate aliquot of Injection for a period of time sufficient to obtain a gamma spectrum.The resultant gamma spectrum should be analyzed for the presence of identifiable photopeaks which are not characteristic of 18Femission:not less than 99.5%of the gamma emissions correspond to the 0.511MeV,1.022MeV,or Compton scatter peaks of 18F.
Other requirements— It meets the requirements under Injections á1ñ,except that the Injection may be distributed or dispensed prior to completion of the test for Sterility á71ñ,the latter test started within 24hours of final manufacture,and except that it is not subject to the recommendation on Volume in Container.
Assay for radioactivity— Using a suitable calibrated system as directed under Radioactivity á821ñ,determine the radioactivity,in MBq (or MCi)per mL,of Injection.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 849
Pharmacopeial Forum:Volume No.27(2)Page 2148
Phone Number:1-301-816-8305