Stable isotopic composition of the active pharmaceutical ingredient (API) naproxen
Copyright policy )Stable isotopic composition of the active pharmaceutical ingredient (API) naproxen
A survey of the multi-stable isotopic composition of an active pharmaceutical ingredient (API), naproxen, was performed to assess the potential of Isotope Ratio Mass Spectrometry (IRMS) to distinguish the provenance of APIs. Twenty-six lots of naproxen from six manufacturers representing four countries (Italy, India, Ireland, and the USA) were analyzed for three isotope ratios (13C/12C, 18O/16O, and D/H). The samples were analyzed by either Elemental Analyzer/Isotope Ratio Mass Spectrometry (EA/IRMS: carbon (delta13C)) or by Thermal Conversion-EA/IRMS (TCEA/IRMS: hydrogen (deltaD) and oxygen (delta18O)). Bivariate and trivariate isotope ratio graphs for naproxen show marked clustering of the data for five out of the six naproxen manufacturers, suggesting that IRMS may be a plausible means to screen for manufacturer of given APIs.
- United States Food and Drug Administration United States
- Center for Drug Evaluation and Research United States
Carbon Isotopes, Naproxen, United States Food and Drug Administration, Anti-Inflammatory Agents, Non-Steroidal, Reproducibility of Results, Oxygen Isotopes, Mass Spectrometry, United States, Hydrogen
Carbon Isotopes, Naproxen, United States Food and Drug Administration, Anti-Inflammatory Agents, Non-Steroidal, Reproducibility of Results, Oxygen Isotopes, Mass Spectrometry, United States, Hydrogen
selected citations These citations are derived from selected sources.This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).25 popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.Top 10% influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).Top 10% impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.Top 10%
Citations provided by BIP!Popularity provided by BIP!