Validation of a good manufacturing practice procedure for the production of [11C]AZD4747, a CNS penetrant KRASG12c inhibitor
Open Access
- 20 December 2023
- journal article
- research article
- Published by Wiley in Journal of Labelled Compounds and Radiopharmaceuticals
- Vol. 67 (6) , 245-249
Abstract
AZD4747 is a KRASG12C inhibitor recently shown to cross the non‐human primate blood‐brain barrier efficiently. In the current study, a GMP‐compliant production of [11C]AZD4747 was developed to enable PET studies in human subjects. The validated procedure afforded [11C]AZD4747 as an injectable solution in good radioactivity yield (1656 ± 532 MBq), excellent radiochemical purity (100%), and a molar activity of 77 ± 13 GBq/μmol at the end of the synthesis, which took 46 ± 1 min from the end of the bombardment. Quality control on the final product was performed satisfactorily and met all acceptance criteria.Keywords
Funding Information
- Knut och Alice Wallenbergs Stiftelse (2018.0066)
- AstraZeneca España
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