Synthesis, characterization, method development, and validation of nor-ethylmorphine hydrochloride reference material using established analytical techniques for dope control analysis

Ethylmorphine is permitted internationally for therapeutic purposes where morphine is not indicated across the globe. Nor-ethylmorphine a major metabolite of ethylmorphine. To differentiate the intake of morphine from ethylmorphine, nor-ethylmorphine stable reference material is desirable. There is no available commercial source and no data for reference material context for this substance. Therefore, nor-ethylmorphine HCl was synthesized and characterized, and purity and potency were assessed using nuclear magnetic resonance (NMR), high-resolution mass spectrometry (HRMS), Fourier transform infrared spectroscopy (FT-IR), thermogravimetry (TGA), and high-performance liquid chromatography (HPLC). Purity and potency were found to be 98.29% and 96.40%, respectively, providing a fit for purpose reference material for doping control analysis in sports.