CPC A61K 51/0478 (2013.01) [A61K 9/19 (2013.01); A61K 31/66 (2013.01); A61K 51/025 (2013.01)] | 20 Claims |
1. A reconstituted radiopharmaceutical composition comprising:
i) a first component comprising an aqueous solution of 99mTc pertechnetate; and
ii) a second component comprising:
a) tetrofosmin disulfosalicylate in an amount between about 13.0-15.0% (w/w) of the second component;
b) gentisic acid in an amount between about 13.54-18.03% (w/w) of the second component;
c) a reducing agent in an amount between about 0.37-0.5% (w/w) of the second component;
d) a transchelator in an amount between about 12.0-16.0% (w/w) of the second component; and
e) sodium bicarbonate at an amount between about 50.0-62.0% (w/w) of the second component,
wherein the tetrofosmin disulfosalicylate and reducing agent are present in a ratio by weight of about 30:1 to about 35:1,
wherein the reconstituted radiopharmaceutical composition is free of ascorbate or ascorbic acid and an antimicrobial preservative, and
the reconstituted radiopharmaceutical composition is reconstituted from the first component and second component, and has a radiochemical purity of at least 90% after 12 hours of storage at a temperature of 2-30° C.
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