Fast Sex Wellness Products Screening Using a Portable/Field Deployable MS Equipped with a Direct Sampling Atmospheric Pressure (DSAP) Source

Abstract Sex-wellness products, including herbal formulations, API-containing tablets, creams, and sprays, are widely used to enhance sexual performance, treat erectile dysfunction, or improve perceived sexual well-being. These products span a broad and heterogeneous market, ranging from regulated prescription pharmaceuticals to over-the-counter (OTC) preparations and illicit or counterfeit (with APIs) products distributed through informal channels and online platforms. Particularly, the circulation of counterfeit, adulterated, or products marketed as alternatives to phosphodiesterase type 5 inhibitors (PDE5i), represents a growing public health challenge, where PDE5i and certain antidepressants and anesthetics used for the treatment of premature ejaculation are often detected in unregulated formulations. Current analytical approaches for illegal substances in these formulations rely predominantly on laboratory-based techniques, such as LC-HRMS/MS, which require time-consuming sample preparation, skilled personnel, and centralized facilities. Faster and cheaper screening approaches, such as immunoassays (e.g., ELISA) and other rapid test kits, widely used due to their simplicity and low cost, are inherently target-specific and may suffer from cross-reactivity or limited selectivity. Portable mass spectrometry (PMS) instrumentation represents an effective alternative, enabling rapid, on-site screening of complex samples with enhanced selectivity and broader detection capabilities. In this work, a miniature ion trap system, equipped with atmospheric pressure chemical ionization (APCI) and thermal desorption (TD), enabling MS and MS/MS analyses with minimal sample preparation, was evaluated for the rapid screening of pharmaceutical compounds in sex-wellness products, including counterfeit and adulterated formulations. Besides qualitative identification, a semiquantitative analysis was also developed to estimate drug concentration. A complementary LC-HRMS/MS analysis provided confirmation and structural elucidation of the compounds detected during on-site screening. The PMS instrumentation provided rapid and reliable screening and semiquantitative capabilities with results consistent with those obtained by LC-HRMS/MS systems.