Comprehensive quality control of the ITG 68Ge/68Ga generator and synthesis of 68Ga-DOTATOC and 68Ga-PSMA-HBED-CC for clinical imaging Academic Article uri icon

Overview

MeSH Major

  • Edetic Acid
  • Octreotide
  • Oligopeptides
  • Organometallic Compounds
  • Radionuclide Generators

abstract

  • The GMP-certified (68)Ge/(68)Ga generator system was studied for a year. The generator system is contained within the fluidic labeling module, and it is compact, self-shielded, and easy to operate using simple manual techniques. The system provides radiolabeled peptides with high (>98%) radiochemical purity and greater than 80% radiochemical yield. The (68)Ge levels in the final drug products were under the detection limits at all times. (68)Ga-DOTATOC and (68)Ga-PSMA-HBED-CC investigational radiopharmaceuticals are currently being studied clinically under investigational new drug (IND) applications submitted to the U.S. Food and Drug Administration.

publication date

  • September 2016

Research

keywords

  • Academic Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.2967/jnumed.115.171249

PubMed ID

  • 27103024

Additional Document Info

start page

  • 1402

end page

  • 5

volume

  • 57

number

  • 9