C6H567GaO7

1,2,3-Propanetricarboxylic acid,2-hydroxy-,gallium-67Ga(1:1)salt.
Gallium-67Gacitrate (1:1) [41183-64-6;52260-70-5].

Packaging and storage— Preserve in single-dose or multiple-dose containers.

Labeling— Label it to include the following,in addition to the information specified for Labelingunder Injections á1ñ:the time and date of calibration;the amount of 67Ga as labeled gallium citrate expressed as total megabecquerels (MBq)(microcuries [µCi]or millicuries [mCi])and concentration as megabecquerels (µCi or mCi)per mLat the time of calibration;the expiration date and time;and the statement “Caution—Radioactive Material.”The labeling indicates that in making dosage calibrations,correction is to be made for radioactive decay,and also indicates that the radioactive half-life of 67Ga is 78.26hours.

USP Reference standards á11ñ— USP Endotoxin RS.

Bacterial endotoxins á85ñ— It meets the requirements of the Bacterial Endotoxins Test,the limit of endotoxin content being not more than 175/VUSP Endotoxin Unit per mLof the Injection,when compared with the USP Endotoxin RS,in which Vis the maximum recommended total dose,in mL,at the expiration date or time.

pHá791ñ: between 4.5and 8.0.

Radiochemical purity— Place 10to 20µLof Injection about 3cm from one end of a 3-×55-cm strip of chromatographic paper (see Chromatography á621ñ).While spots are wet,immediately develop the chromatogram at room temperature to the 14-cm mark by ascending chromatography,using a solvent system consisting of a mixture of 1.36g of sodium acetate and 0.58mLof glacial acetic acid in each 100mLof water.Allow the strip to partially dry,cover with clear tape,and determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector:not less than 97.0%of the total radioactivity is found as gallium citrate when measured at the solvent front (RFvalue equal to or greater than 0.9).

Radionuclide identification (see Radioactivity á821ñ)— Its gamma-ray spectrum is identical to that of a specimen of 67Ga of known purity that exhibits major photopeaks having energies of 93.3,184.6,and 300.2KeV.

Radionuclidic purity— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radionuclidic purity of the Injection:not less than 99%of the total radioactivity is present as 67Ga at the time of calibration.

Other requirements— It meets the requirements under Injections á1ñ,except that the Injection may be distributed or dispensed prior to the completion of the test for Sterility,the latter test being started on the day of manufacture,and except that it is not subject to the recommendation on Volume in Container.

Assay for radioactivity— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radioactivity in MBq (µCi or mCi)per mLof Gallium Ga 67Injection by use of a calibrated system as directed under Radioactivity á821ñ.

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 888

Phone Number:1-301-816-8305