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823
). It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 18F expressed in MBq (mCi) per mL at the time indicated in the labeling. It may contain suitable preservatives and/or stabilizing agents.1: the time and date of calibration; the amount of 18F as fludeoxyglucose expressed as total MBq (mCi) per mL, at time of calibration; the expiration time and date; the name and quantity of any added preservative or stabilizer; and the statement “Caution—Radioactive Material.” The labeling indicates, that in making dosage calculations, correction is to be made for radioactive decay. The radioactive half-life of 18F is 109.7 minutes. The label indicates “Do not use if cloudy or if it contains particulate matter.”
11—
USP Endotoxin RS.USP Fludeoxyglucose RS. USP Fludeoxyglucose Related Compound A RS. USP Fludeoxyglucose Related Compound B RS.
821), is between 105 and 115 minutes.
85 (see Sterilization and Sterility Assurance under Radiopharmaceuticals for Positron Emission Tomography—Compounding 823)—
It contains not more than 175/V USP Endotoxin Unit per mL of the Injection, in which V is the maximum administered total dose, in mL, at the expiration time.
791:
between 4.5 and 7.5.
621). Apply about 10 µg of the Standard solution to the same chromatographic plate. Develop the chromatogram in a solvent system consisting of a mixture of acetonitrile and water (95:5) until the solvent has moved about three-fourths of the length of the plate. Remove the plate, and allow the chromatogram to dry. Determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector. Determine the location of the Fludeoxyglucose by spraying the developed chromatographic plate with 2 N sulfuric acid and heating the plate at 110
for 10 minutes: the RF value of Fludeoxyglucose F 18 (determined by radiochromatogram scanning) corresponds to that of the Standard solution (about 0.4); the radioactivity of Fludeoxyglucose F 18 is not less than 90% of the total radioactivity.
821), count an appropriate aliquot of the Injection for a period of time sufficient to collect a gamma spectrum. The resultant gamma spectrum should be analyzed for the presence of identifiable photopeaks which are not characteristic of 18F emissions. Not less than 99.5% of the observed gamma emissions should correspond to the 0.511 MeV, 1.022 MeV, or Compton scatter peaks of 18F.
823). Any ingredients with toxic potential must be within appropriate limits, and conformance with these limits is to be demonstrated by the use of one or more validated limit tests.]
621. Place the plate in a chamber containing iodine crystals. Develop the plate until a spot is visible on the chromatogram of the Standard solution: the size and intensity of the spot obtained from the Test solution does not exceed that obtained from the Standard solution.
621)—
The liquid chromatograph is equipped with a pulsed amperometric detector and a 4.0-mm × 25-cm column that contains 10-µm packing L46. The flow rate is adjusted to about 0.5 mL per minute. Chromatograph the Standard solution and the System suitability solution, and record the peak responses as directed for Procedure: the resolution, R, between fludeoxyglucose and fludeoxyglucose related compound B is not less than 1.5; and the relative standard deviation for replicate injections is not more than 5%.
621)—
The gas chromatograph is equipped with a flame-ionization detector, a splitless injector system, and a 0.53-mm × 30-m fused-silica column coated with a 0.25-µm, chemically cross-linked G16 stationary phase. The carrier gas is helium, flowing at a rate of 10 mL per minute. (Nitrogen may be used as a makeup gas.) The chromatograph is programmed as follows. Initially the temperature is maintained at 40 for 2 minutes, then the temperature is increased at a rate of 20 per minute to 130, and maintained at 130 for 5.5 minutes. The injection port and detector temperatures are maintained at 250 and 300, respectively. Inject the Standard solutions, and record the identity peak responses as directed for Procedure: the resolution, R, between any two components is not less than 1.0; and the relative standard deviation for replicate injections is not more than 5%.
1, except that the Injection may be distributed or dispensed prior to completion of the test for Sterility 71, the latter test being started within 24 hours of final manufacture, and except that it is not subject to the recommendation of Volume in Container.
821, determine the radioactivity in MBq (or mCi) per mL, of the Injection.