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Published on: August 22, 2017
Identification and quantification of a novel PDE-5 inhibitor, Dasantafil, found as an adulterant in a pressed candy
Aliang Peng1, Jian Sun2, Jingxian Zhang2
1School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China; NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine, Shanghai Institute for Food and Drug Control, Shanghai 201203, China.
Abstract:
During non-targeted screening of a pressed candy dietary supplement, an unidentified compound was detected and subsequently isolated through prep-HPLC. Comprehensive structural elucidation employing high-performance liquid chromatography-diode array detection (HPLC-DAD), ultra-high-performance liquid chromatography-quadrupole time-of-flight tandem mass spectrometry (UHPLC/Q-TOF MS), and one-dimensional (1D) and two-dimensional (2D) nuclear magnetic resonance (NMR) spectroscopy confirmed the compound as Dasantafil (C22H28N5O5Br), a phosphodiesterase-5 (PDE-5) inhibitor. HPLC quantification revealed a content of 9.31 mg/g for the compound in the pressed candy. This study represents the first documented case of Dasantafil adulteration in health products. The compound possesses a unique xanthine-based scaffold that is structurally distinct from conventional PDE-5 inhibitors, highlighting the need for updated regulatory monitoring of novel PDE-5 inhibitor analogs in dietary supplements.

