Ensure the authenticity of antibiotic vials: An independent testing protocol using attenuated total reflection infrared spectroscopy and Raman spectroscopy

Abstract

The burgeoning global pharmaceutical market has witnessed a concurrent surge in counterfeit drug proliferation, particularly in developing countries. Counterfeit antibiotics pose a significant threat to public health, potentially leading to treatment failures, antibiotic resistance, and even fatalities. This study presents an innovative independent testing protocol employing Raman spectroscopy and attenuated total reflection infrared spectroscopy (ATR-IR) for the rapid and accurate detection of counterfeit antibiotic vials. These rapid, eco-friendly, and non-destructive techniques enable the acquisition of critical information about the analyzed samples. However, while ATR-IR preserves the chemical composition and structural integrity of the sample, physical contact with the ATR crystal may prevent complete sample recovery. The combination of ATR-IR and Raman spectroscopy leverages their distinct analytical principles ATR-IR detecting polar asymmetric vibrations (dipole moment variations) and Raman identifying symmetric vibrations (polarizability changes) to provide a robust and reliable solution for detecting counterfeit antibiotics. Both Raman spectroscopy and ATR-IR demonstrated exceptional precision and specificity of 100 %, underscoring the model remarkable reliability in counterfeit classification (all counterfeit samples were successfully rejected). Fluorescence backgrounds in Raman spectroscopy were mitigated by employing a 1064 nm laser wavelength, enhancing its applicability for complex matrices. Our Independent Testing Protocol presents a promising solution to the complex issue of counterfeit antibiotic vial detection. By synergizing the strengths of Raman spectroscopy and ATR-IR, we achieve a comprehensive and reliable assessment of antibiotic vials, thereby contributing to patient safety and public health protection.