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Synthesis, characterization, method development, and validation of nor-ethylmorphine hydrochloride reference material
Sachin D Pawar1, Gangasani J Kumar1, Aruna Chikkondra1
1Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research-Guwahati (NIPER-Guwahati), Guwahati, Assam, India.
Abstract:
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.
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