1. Compatibility of [99mTc]Tc-EDDA/HYNIC-TOC and [68Ga] Ga-DOTA-TOC in a syringe for intravenous administration
- Author
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Philip Chennell, Sarah Chaib, Isabelle Morelec, Caroline Darcissac, Catherine Rioufol, Valérie Sautou, F. Hallouard, Marc Fraysse, Laboratoire de Pharmacie Galenique, Biopharmacie et Pharmacie Clinique, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), CHU Clermont-Ferrand, Ciblage thérapeutique en Oncologie (EA3738), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Unité de Radiopharmacie - Service de Pharmacie [Pierre-Bénite], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Laboratoire de Pharmacie Galenique, Biopharmacie et Pharmacie Clinique [Rennes], and Université de Rennes (UR)
- Subjects
Drug ,Quality Control ,Medical device ,media_common.quotation_subject ,[SDV]Life Sciences [q-bio] ,Octreotide ,Dosage form ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Organometallic Compounds ,DOTA ,Radiology, Nuclear Medicine and imaging ,Syringe ,Edetic Acid ,media_common ,Chromatography ,Chemistry ,Syringes ,Nicotinic Acids ,Sorption ,General Medicine ,Organotechnetium Compounds ,3. Good health ,Drug quality ,Drug concentration ,030220 oncology & carcinogenesis ,Administration, Intravenous ,Drug Contamination - Abstract
International audience; Objective Drug quality in medical devices is not evaluated during the marketing authorization of radiopharmaceuticals. Therefore, the extemporaneous change of packaging made for preparation of patient unit doses in a syringe is the responsibility of radiopharmacists. The present study aimed to determine the impact of packaging and storage in a polypropylene syringe on the quality of hydrophilic drugs [99mTc]Tc-EDDA/HYNIC-TOC (Tektrotyd) and [68Ga]Ga-DOTA-TOC (Somakit-TOC).Methods Appearance, pH, radiochemical purity, sterility, and endotoxin tests were performed according the current European Pharmacopoeia. Subvisible and visible particles tests of the European Pharmacopoeia were adapted due to limited preparation volume (
- Published
- 2020
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