Radiopharmaceutical products

An imaging agent product comprising a tetrofosmin composition within a sealed container,

• the sealed container comprising a pharmaceutical grade glass vial and pre-treated closure suitable for puncturing with a hypodermic needle while maintaining seal integrity, the pre-treated closure comprising a chlorinated butyl rubber body which is coated with ethylene-tetrafluoroethylene copolymer (ETFE) on one or more of its surface(s) which are in contact with the container contents, wherein the pre-treatment of the closure removes oxygen gas dissolved within the closure material so that the sealed container exhibits a headspace having an increase in oxygen of less than 2 microliters after 11 weeks post-sealing;
• the tetrofosmin composition comprises a lyophilized, non-radioactive formulation having a pH in the range of 8.0 to 9.2 in the sealed container, the formulation comprising:
• (i) a tetrofosmin precursor,
• (ii) an optional radioprotectant selected from ascorbic acid or a salt thereof with a biocompatible cation;
• (iii) a biocompatible reductant that comprises stannous ion;
• and
• (iv) an effective amount of a pH-adjusting agent that is sodium bicarbonate, sodium hydrogen carbonate, or a combination thereof;
• wherein the tetrofosmin composition is sealed within the sealed container under nitrogen gas with the pre-treated closure such that the sealed container exhibits reduced losses of tetrofosmin relative tetrofosmin compositions sealed within a container having an uncoated rubber body, and wherein upon reconstitution with 99mTc the imaging agent the product yields a 99mTc-tetrofosmin imaging agent.