Medronate (MDP+)
Kit for the Preparation of Technetium Tc 99m Medronate Injection
DIAGNOSTIC
For Intravenous Use
DESCRIPTION
The kit consists of reaction vials which contain the sterile, nonpyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by intravenous injection. Each 10 mL reaction vial contains 10.0 mg of medronic acid (as the sodium salt), 1.1 mg of stannous chloride dehydrate and 2.0 mg of p-aminobenzoic acid in lyophilized form under an atmosphere of nitrogen. Sodium hydroxide and/or hydrochloric acid has been used for pH adjustment. The addition of sterile, non-pyrogenic, and oxidant-free sodium pertechnetate Tc 99m solution produces a rapid labelling which is essentially quantitative and which remains stable in vitro throughout the 12-hour life of the preparation. The pH of the reconstituted radiopharmaceutical is 6.5 to 7.5. No bacteriostatic preservative is present.