ArticleEJNMMI radiopharmacy and chemistry2025
Stability assessment of PET radiopharmaceuticals under extreme conditions: an ICH-compliant study on radiochemical and enantiomeric purity.
Article in EJNMMI radiopharmacy and chemistry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe stability testing of radiopharmaceuticals is a critical aspect of drug development and regulatory approval. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) provides comprehensive guidelines for stability testing, as outlined in the ICH Harmonised Tripartite Guideline Q1A(R2). In this study, the stability of o-(2-[
resultsSamples from each batch were tested at different temperatures and pH values across the entire expiration period. The radiochemical purity of [
conclusionIn this report, the stability of the [
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