Pharmaceutical composition comprising tetrofosmin and pharmaceutically acceptable salts thereof

A reconstituted radiopharmaceutical composition comprising:

• a first component comprising a saline solution of 99mTc pertechnetate and water;
• and
• a second component comprising (i) tetrofosmin disulfosalicylate in an amount between about 13.0-15.0% (w/w) of the second component;
• (ii) gentisic acid in an amount between about 13.54-18.03% (w/w) of the second component;
• (iii) stannous chloride dihydrate in an amount between about 0.37-0.5% (w/w) of the second component,
• wherein the tetrofosmin disulfosalicylate and stannous chloride dihydrate are present in a ratio by weight of about 30:1 to about 35:1,
• wherein the second component comprises less than 1% w/w dioxo tetrofosmin (TFS-2) content and less than 1% w/w mono-oxo tetrofosmin content, and
• wherein the liquid radiopharmaceutical composition is free of ascorbate or ascorbic acid and an antimicrobial preservative, and has a radiochemical purity of at least 90% after 12 hours of storage at a temperature of 2-30° C.

A reconstituted radiopharmaceutical composition comprising:

• a first component consisting of a saline solution of 99mTc pertechnetate and water;
• and
• a second component comprising (i) tetrofosmin disulfosalicylate in an amount equivalent to tetrofosmin between 1.24-1.52 mg/vial;
• (ii) gentisic acid in an amount between 2.7-3.3 mg/vial;
• (iii) stannous chloride dihydrate in an amount between about 0.08 mg-0.1 mg/vial;
• (iv) sodium gluconate in an amount between about 2.6 mg-3.4 mg/vial;
• and (v) sodium bicarbonate at an amount between about 10 mg-12 mg/vial,
• wherein the tetrofosmin disulfosalicylate and stannous chloride dihydrate are present in a ratio by weight of about 30:1 to about 35:1,
• wherein the second component comprises less than 1% w/w dioxo tetrofosmin (TFS-2) content and less than 1% w/w mono-oxo tetrofosmin content, and
• wherein the liquid radiopharmaceutical composition is free of ascorbate or ascorbic acid and an antimicrobial preservative, and has a radiochemical purity of at least 90% after 12 hours of storage at a temperature of 2-30° C.