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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.
A stable reference material for nor-ethylmorphine, a key metabolite of ethylmorphine, was synthesized. This new material is crucial for accurately differentiating ethylmorphine intake in sports doping control analysis.
Area of Science:
- Forensic Chemistry
- Analytical Chemistry
Background:
- Ethylmorphine is used therapeutically worldwide where morphine is not indicated.
- Nor-ethylmorphine is a major metabolite of ethylmorphine.
- A stable reference material for nor-ethylmorphine is needed to distinguish ethylmorphine from morphine intake, but none is commercially available.
Purpose of the Study:
- To synthesize and characterize nor-ethylmorphine hydrochloride (HCl) as a reference material.
- To establish purity and potency data for the synthesized nor-ethylmorphine HCl.
- To provide a fit-for-purpose reference material for doping control analysis.
Main Methods:
- Synthesis of nor-ethylmorphine HCl.
- Characterization using Nuclear Magnetic Resonance (NMR) and High-Resolution Mass Spectrometry (HRMS).
- Purity and potency assessment via Fourier Transform Infrared Spectroscopy (FT-IR), Thermogravimetry (TGA), and High-Performance Liquid Chromatography (HPLC).
Main Results:
- Nor-ethylmorphine HCl was successfully synthesized and characterized.
- Purity was determined to be 98.29%.
- Potency was determined to be 96.40%.
Conclusions:
- The synthesized nor-ethylmorphine HCl serves as a reliable reference material.
- This material is suitable for doping control analysis in sports.
- It enables accurate differentiation between ethylmorphine and morphine intake.
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