Mespiperone C 11 Injection
» Mespiperone C 11 Injection is a sterile, isotonic solution, suitable for intravenous administration, of 3N-[11C] methylspiperone in which a portion of the 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 GBq (or mCi) at the time indicated in the labeling. Its specific activity is not less than 18.5 GBq (500 mCi) per µmol.
Specific activity
Chromatographic system
Proceed as directed in the test for Chemical purity.
Procedure
Calculate the specific activity, in MBq (or mCi) per µmol, of Mespiperone C 11 Injection by the formula:
3.11(Cr Pr) / C
in which Cr is the radioactivity content, in MBq (or mCi) per mL, as determined in the Assay for radioactivity, Pr is the radiochemical purity (in %), as determined in the test for Radiochemical purity, and C is the concentration (in µg per mL) of 3-methylspiperone in the Injection, as determined in the test for Chemical purity.
Packaging and storage
Preserve in single-dose or in multiple-dose containers that are adequately shielded.
Labeling
Label it to include the following: the time and date of calibration; the amount of 11C as methylspiperone expressed as total GBq (or mCi) at time of calibration; the expiration time and date; the lot or batch number; and the statements, CautionRadioactive Material and Do not use if cloudy or if it contains particulate matter. The labeling indicates that in making dosage calculations correction is to be made for radioactive decay, and states that the radioactive half-life of 11C is 20 minutes.
Radionuclide identification (see Radioactivity
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Bacterial endotoxins
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pH
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Radionuclidic purity
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Chemical purity
Mobile phase
Prepare a filtered and degassed mixture of acetonitrile and 0.05 M monobasic potassium phosphate (70:30). Make adjustments if necessary (see System Suitability under Chromatography
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Standard solution
Dissolve an accurately weighed quantity of 3-methylspiperone hydrochloride in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 0.1 mg per mL.
Test solution
Pipet an accurately measured volume of Injection into a suitable container, and dilute with Mobile phase to obtain a solution containing about 0.1 mg per mL.
Chromatographic system
(see Chromatography
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Procedure
Inject about 20 µL of the Test Solution into the chromatograph, record the chromatogram, and measure the peak responses. Separately calculate the percentage of each impurity in the portion of Injection taken by the formula:
100(ri / rs)
in which ri is the peak response obtained for each impurity, and rs is the sum of the responses of all of the peaks: not more than 0.2% of any individual impurity is found, and the sum of all impurities is not more than 0.9%.
Radiochemical purity
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Other requirements
It meets the requirements under Injections
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Assay for radioactivity
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Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 1794
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