Stabilized radiopharmaceutical compositions

A stabilized radiopharmaceutical composition, comprising:

• a) Flurpiridaz F-18;
• b) effective amount of at least one stabilizer selected from the group consisting of gentisic acid, sodium gentisate, ascorbyl alcohol, gentisyl alcohol, maleic acid, cysteine, cystamine hydrochloride, methionine, niacinamide, nicotinic acid, p-amino benzoic acid, benzyl alcohol, meglumine and its derivatives, a polyaminoacid polymer and combinations thereof;
• wherein, the pH of the composition is from 4 to 9;
• wherein, the composition is free of cyclodextrin and derivatives thereof;
• wherein, the composition is free of ascorbic acid or a salt thereof;
• wherein the total stabilizer concentration in the composition ranges from about 5 mg/ml to 100 mg/ml;
• wherein, the bacterial endotoxin content in the composition is not more than 10 EU/ml;
• wherein, the content of total impurities is not more than 5% and any individual impurities content is not more than 1%;
• wherein the radioactivity concentration of the composition is in the range of 100 MBq/mL to 5000 MBq/mL;
• wherein the initial radiochemical purity of the composition is at least 95% immediately after radiolabeling;
• and
• wherein the radiochemical purity of the composition is at least 90% at 10 hours after end of synthesis when stored at a temperature ranging from 2° C. to 30° C.

A stabilized radiopharmaceutical composition, comprising:

• a) a Fluorine-18 labelled compound;
• b) an effective amount of at least one stabilizer selected from the group consisting of gentisic acid, sodium gentisate, ascorbyl alcohol, gentisyl alcohol, maleic acid, cysteine, cystamine hydrochloride, methionine, niacinamide, nicotinic acid, p-amino benzoic acid, benzyl alcohol, 5-hydroxy L-tryptophan, 2-aminothiazoline hydrobromide, S-(2-Aminoethyl)thiouronium bromide hydrobromide, meglumine and its derivatives, a polyaminoacid polymer, dimercaptosuccinic acid, vanillin, adenine, dobesilic acid, thymine, uracil, sodium thiosulfate, sodium sulfite, sodium metabisulfite and combinations thereof;
• wherein, the pH of the composition is from 4 to 9;
• wherein, the composition is free of cyclodextrin and derivatives thereof;
• wherein, the composition is free of ascorbic acid or a salt thereof;
• wherein the initial radiochemical purity of the composition is at least 95% immediately after radiolabeling and wherein the shelf-life of the composition is at least 8 hours after end of synthesis when stored at a temperature ranging from 2° C. to 30° C.