Packaging and storage— Preserve in adequately shielded single-dose or in multiple-dose containers. Protect from light. Store at a temperature not exceeding 25.

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 99mTc as labeled tetrofosmin expressed as total MBq (or mCi) and the concentration as megabecquerels per mL (or as mCi per mL) on the date and time of calibration; the expiration date and time; and a 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 99mTc is 6.0 hours.

USP Reference standards 11— USP Endotoxin RS.

Bacterial endotoxins 85— The limit of endotoxin content is not more than 175/V USP Endotoxin Unit per mL of the Injection, when compared with USP Endotoxin RS, in which V is the maximum recommended total dose, in mL, at the expiration date or time.

pH 791: between 8.3 and 9.1.

Radiochemical purity— To determine the amount of free technetium, apply a 10- to 20-µL volume of Injection about 3.0 cm from the bottom of a 2- × 20-cm instant thin-layer chromatographic silica gel strip (see Chromatography 621). Immediately develop the chromatogram by ascending chromatography to a height of 15 cm using a solvent system consisting of a mixture of acetone and dichloromethane (35:65). Allow the chromatogram to air-dry. Determine the radioactivity distribution of the chromatogram by scanning with a suitable radiation detector. The RF value of the technetium Tc 99m tetrofosmin spot is approximately 0.5: the sum of radioactivity at the solvent front (unbound pertechnetate) and the origin (reduced hydrolyzed technetium and hydrophilic impurities) is not more than 10%.

Other requirements— It meets the requirements for Radionuclide identification and Radionuclidic purity under Sodium Pertechnetate Tc 99m Injection. It meets also the requirements under Injections 1, except that it may be distributed or dispensed prior to completion of the test for Sterility, the latter test being started on the date of manufacture.

Assay for radioactivity 821— Using a suitable counting assembly (see Selection of a Counting Assembly), determine the radioactivity, in MBq (µCi) per mL, of the Injection by use of a calibrated system.

Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05

USP29–NF24 Page 2077

Phone Number : 1-301-816-8305