Sodium Acetate C11Injection
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»Sodium Acetate C11Injection 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 90.0percent and not more than 110.0percent of the labeled amount of 11Cexpressed in MBq (or in µCi or mCi)at the time indicated in the labeling.It may contain suitable buffers.
Specific activity:
not less than 3.7GBq (100mCi)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 Labelingunder Injections á1ñ:the time and date of calibration;the amount of 11Cas 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 11Cis 20minutes.
Radionuclide identification á821ñ—
Its gamma-ray spectrum is identical to that of a specimen of 11Cin that it exhibits a positron annihilation peak at 0.511MeVand possibly a sum peak of 1.022MeV,dependent upon geometry and detector efficiency.
Bacterial endotoxins á85ñ—
It contains not more than 175/VUSP Endotoxin Unit per mL,in which Vis the maximum recommended total dose,in mL,at the expiration date or time.
pHá791ñ:
between 4.5and 8.5.
Radionuclidic purity á821ñ—
Amultichannel analyzer is used to count all radioactivity from 40to 2,500keVto determine the absence of radiation,other than at 0.511MeVand 1.022MeV,over a period of 4hours.Determine the half-life by a suitable detector system.
Chemical purity—
Mobile phase—
Add 14mLof 0.5Nsulfuric acid to 500mLof water in a 1000-mLvolumetric flask.Add 100mLof acetonitrile,dilute with water to volume,and mix.Filter and degas.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Reference solution—
Dissolve an accurately weighed quantity of sodium acetate in water to obtain a solution having a known concentration of about 1mg per mL.Quantitatively dilute a portion of this solution with Mobile phaseto obtain a solution having a known concentration of about 20µg per mL.
Test solution—
Prepare a solution by quantitatively diluting an accurately measured volume of Injection,equivalent to about 1mCi of radioactivity with 10parts of Mobile phase,and mix.
Chromatographic system
(see Chromatography á621ñ)—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 1mLper minute.Chromatograph the Reference solution,and record the peak responses as directed for Procedure:the relative retention times are about 0.8minutes for acetate and 1.0minute for carbonate,the resolution,R,between acetate and carbonate is not less than 1.4,the column efficiency is not less than 85theoretical plates,and the relative standard deviation for replicate injections is not more than 10%.
Procedure—
Separately inject equal volumes (about 50µL)of the Reference solutionand the Test solutioninto 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 Cis the concentration,in g per mL,of sodium acetate in the Reference solution,and rUand rSare the acetate peak responses obtained from the Test solutionand the Reference solution,respectively.
Radiochemical purity—
Chromatographic system—
Proceed as directed under Chemical purityexcept that the liquid chromatograph is also equipped with a suitable collimated radiation detector (see Radioactivity á821ñ).
Procedure—
Inject about 30µLof the Injection into the chromatograph,record the chromatogram,and measure the areas for the major peaks.The radioactivity under the acetate C11peak 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 á1ñ,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 á821ñ—
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.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 353
Phone Number:1-301-816-8305