High purity copper radiopharmaceutical compositions and diagnostic and therapeutic uses thereof

A pharmaceutical composition comprising a compound and a pharmaceutically acceptable excipient, wherein the compound is of Formula 30:

• or is a pharmaceutically acceptable salt thereof;
• wherein:
• R1 is Ra;
• R2 and R3 are each Ra or together form a C2-9 heterocycle with the nitrogen atoms to which they are attached;
• Ra, independently for each occurrence, is selected from H, C1-10 alkyl, C2-10 alkenyl, C3-10 alkynyl, C3-10 cycloalkyl, C6-10 aryl, C2-9 heterocyclyl, or C5-9 heteroaryl, wherein each C1-10 alkyl, C2-10 alkenyl, C3-10 alkynyl, C3-10 cycloalkyl, C6-10 aryl, C2-9 heterocyclyl, or C5-9 heteroaryl is optionally substituted by one or more substituents selected from —OH, —OR′, ═O, ═S, —SH, —SR′, —NH2, —NHR′, —N(R′)2, —NHCOR′, —NR′COR′, halogen, —CN, —CO2H, —CO2R′, —CHO, —COR′, —CONH2, —CONHR′, —CON(R′)2, —NO2, —OP(O)(OH)2, —SO3H, —SO3R′, —SOR′, and —SO2R′, wherein R′, independently for each occurrence, is C1-10 alkyl or C3-10 cycloalkyl;
• n is an integer from 1 to 20;
• m is an integer from 1 to 20;
• and
• *Cu is 61Cu obtained by deuteron irradiation of natNi or 60Ni on a niobium backing or by proton irradiation of 61Ni on a niobium backing;
• and
• wherein
• (a) the composition is characterized at end of synthesis by radiochemical purity of ≥95%;
• (b) the composition is characterized at end of synthesis by radionuclidic purity for 61Cu of ≥99.999%;
• (c) the 61Cu is characterized at end of synthesis by sum of radionuclidic impurities of ≤6000 Bq/g;
• (d) the 61Cu is characterized at end of synthesis +12 hours by radionuclidic purity of ≥99.985%;
• or
• (e) the 61Cu is characterized at end of synthesis by 56Co activity concentration of ≤800 Bq/g and 58Co activity concentration of ≤800 Bq/g.