Sodium Acetate C 11 Injection
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» Sodium Acetate C 11 Injection is a sterile solution, suitable for intravenous administration, of Sodium Acetate in which a portion of the carboxyl molecules are labeled with radioactive 11C. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 11C expressed in MBq (or in µCi or mCi) at the time indicated in the labeling. It may contain suitable buffers.
Specific activity: not less than 3.7 GBq (100 mCi) per µmol.
Packaging and storage— Preserve in single-dose or in multiple-dose containers that are adequately shielded.
Labeling— Label it to include the following, in addition to the information specified for Labeling under Injections 1: the time and date of calibration; the amount of 11C as labeled sodium acetate expressed as total MBq (or mCi) and the concentration as megabecquerels per mL (or as millicuries per mL), on the date and time of calibration; the expiration date and time; the lot or batch number; the name and quantity of any added preservative or stabilizer; an indication on the labeling that states, “Do not use if cloudy or if it contains particulate matter;” and the statement “Caution—Radioactive Material.” The labeling indicates that in making dosage calculations, correction is to be made for radioactive decay, and also indicates that the radioactive half-life of 11C is 20 minutes.
USP Reference standards 11
USP Endotoxin RS
Radionuclide identification 821 Its gamma-ray spectrum is identical to that of a specimen of 11C in that it exhibits a positron annihilation peak at 0.511 MeV and possibly a sum peak of 1.022 MeV, dependent upon geometry and detector efficiency.
Bacterial endotoxins 85 It contains not more than175/V USP Endotoxin Unit per mL, in which V is the maximum recommended total dose, in mL, at the expiration date or time.
pH 791: between 4.5 and 8.5.
Radionuclidic purity 821 A multichannel analyzer is used to count all radioactivity from 40 to 2,500 keV to determine the absence of radiation, other than at 0.511 MeV and 1.022 MeV, over a period of 4 hours. Determine the half-life by a suitable detector system.
Chemical purity—
Mobile phase— Add 14 mL of 0.5 N sulfuric acid to 500 mL of water in a 1000-mL volumetric flask. Add 100 mL of acetonitrile, dilute with water to volume, and mix. Filter and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Reference solution— Dissolve an accurately weighed quantity of sodium acetate in water to obtain a solution having a known concentration of about 1 mg per mL. Quantitatively dilute a portion of this solution with Mobile phase to obtain a solution having a known concentration of about 20 µg per mL.
Test solution— Prepare a solution by quantitatively diluting an accurately measured volume of Injection, equivalent to about 1 mCi of radioactivity with 10 parts of Mobile phase, and mix.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 210-nm detector and a 7.8-mm × 10-cm column that contains packing L9. The flow rate is about 1 mL per minute. Chromatograph the Reference solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.8 minutes for acetate and 1.0 minute for carbonate; the resolution, R, between acetate and carbonate is not less than 1.4; the column efficiency is not less than 85 theoretical plates; and the relative standard deviation for replicate injections is not more than 10%.
Procedure— Separately inject equal volumes (about 50 µL) of the Reference solution and the Test solution into the chromatograph, record the chromatograms, and measure the responses for the acetate peaks. Calculate the concentration, in µg per mL, of sodium acetate in the Injection by the formula:
C(rU / rS)
in which C is the concentration, in g per mL, of sodium acetate in the Reference solution; and rU and rS are the acetate peak responses obtained from the Test solution and the Reference solution, respectively.
Radiochemical purity—
Mobile phase and Reference solution—Proceed as directed under Chemical purity.
Chromatographic system— Proceed as directed under Chemical purity except that the liquid chromatograph is also equipped with a suitable collimated radiation detector (see Radioactivity 821).
Procedure— Inject about 30 µL of the Injection into the chromatograph, record the chromatogram, and measure the areas for the major peaks. The radioactivity under the acetate C 11 peak is not less than 95% of the total area of all peaks observed, and its retention time is within ±10% of that obtained for the Reference solution, similarly chromatographed.
Other requirements— It meets the requirements under Injections 1, except that the Injection may be distributed or dispensed prior to completion of the test for Sterility, the latter test being started on the day following final manufacture, and except that it is not subject to the recommendation of Volume in Container.
Assay for radioactivity 821 Using a suitable counting assembly (see Selection of a Counting Assembly), determine the radioactivity in MBq (mCi) per mL, of the Injection by use of a calibrated system.
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