Validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) method for analysis of [ 11 C]Nicotine
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Validation of a reversed‑phase high‑performance liquid chromatography (RP‑HPLC) method for analysis of [11C]Nicotine Arijit Ghosh1 · Karen Woolum1 · Michael V. Knopp1 · Krishan Kumar1 Received: 4 August 2020 / Accepted: 15 October 2020 © Akadémiai Kiadó, Budapest, Hungary 2020
Abstract Validated analytical methods must be used for accurate and precise determination of identity, purity, strength, and quality of any pharmaceutical dose intended for human administration. Consequently, all analytical methods must be validated per USP and the ICH Q2R1 guidelines to meet the cGMP requirements of the FDA and EMA. A reversed-phase high-performance liquid chromatography analytical method, with 99.9%), and molar activity (3.885 GBq/µmol), and non-detectable unreacted [ 11C]CH3I and (±) nornicotine. The radiochemical yield of the reaction was 23.9 ± 9.7% (n = 3). An analytical RP-HPLC method, with (1)
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