The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?

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dc.contributor.authorLe Roux, Jannieen_ZA
dc.contributor.authorKleynhans, Jankeen_ZA
dc.contributor.authorRubow, Sietskeen_ZA
dc.date.issued2021-04-01
dc.descriptionCITATION: Le Roux, J., Kleynhans, J. & Rubow, S. 2021. The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?. EJNMMI Radiopharmacy and Chemistry, 6:15, doi:10.1186/s41181-021-00129-w.
dc.descriptionThe original publication is available at https://ejnmmipharmchem.springeropen.com
dc.description.abstractENGLISH ABSTRACT: HEPES (4-(2-hydroxyethyl) piperazine-1-ethanesulfonic acid) is a buffer that is used in the radiolabelling of gallium-68 compounds. The beneficial effects of HEPES on molar activity in bioconjugates have been well described. Current strict regulations on the HEPES content in radiopharmaceuticals limit its use when intended for parenteral administration. This short communication summarizes data from the literature on the toxicity of HEPES in dogs after intravenous infusion and the subsequent use in humans. We also highlight the use of HEPES in an FDA labelled intravenous drug formulation. Regulatory institutions may consider this data to review current strict limits.en_ZA
dc.description.urihttps://ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-021-00129-w
dc.description.versionPublisher's version
dc.format.extent4 pagesen_ZA
dc.identifier.citationLe Roux, J., Kleynhans, J. & Rubow, S. 2021. The use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?. EJNMMI Radiopharmacy and Chemistry, 6:15, doi:10.1186/s41181-021-00129-w
dc.identifier.issn2365-421X (online)
dc.identifier.otherdoi:10.1186/s41181-021-00129-w
dc.identifier.urihttp://hdl.handle.net/10019.1/110405
dc.language.isoen_ZAen_ZA
dc.publisherSpringerOpen (part of Springer Nature)en_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectHEPESen_ZA
dc.subjectRadiopharmaceuticalsen_ZA
dc.subjectGalliumen_ZA
dc.subjectPharmacopoeiasen_ZA
dc.titleThe use of HEPES-buffer in the production of gallium-68 radiopharmaceuticals – time to reconsider strict pharmacopoeial limits?en_ZA
dc.typeArticleen_ZA
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