Demonstration of an End-To-End Workflow Using Atmospheric Solids Analysis Probe-Mass Spectrometry (ASAP-MS) With...

Area of Science:

• Forensic Chemistry
• Analytical Chemistry
• Pharmaceutical Sciences

Background:

• Counterfeit pharmaceuticals pose significant risks to patient safety and financial/reputational integrity of genuine drug manufacturers.
• Rapid analytical methods are crucial for law enforcement and pharmaceutical companies to identify and address the circulation of falsified medicines.
• Mass spectrometry (MS) is a common technique in forensic analysis, but speed and ease of use are critical for in-field applications.

Purpose of the Study:

• To evaluate atmospheric solids analysis probe-mass spectrometry (ASAP-MS) as a rapid and user-friendly method for analyzing pharmaceutical tablets.
• To assess the potential of integrating ASAP-MS with real-time sample recognition software for non-expert use.
• To achieve fast and accurate authentication of pharmaceutical tablets to aid in controlling counterfeit drug trade.

Main Methods:

• Utilized an atmospheric solids analysis probe coupled with mass spectrometry (ASAP-MS) on a commercially available instrument.
• Employed real-time sample recognition software to classify tablets without requiring specialized mass spectrometry interpretation skills.
• Tested the method on five unknown tablets: two authentic pharmaceuticals, one placebo, and two counterfeits with altered active pharmaceutical ingredient (API) quantities and excipient profiles.

Main Results:

• The ASAP-MS method, combined with recognition software, achieved tablet classification in under 2 minutes.
• The end-to-end workflow demonstrated 100% success in authenticating the five tested tablets (authentic, placebo, and counterfeit).
• The system proved effective for non-scientists, enabling rapid, data-led decisions in field settings.

Conclusions:

• ASAP-MS offers a fast, simple, and effective solution for identifying counterfeit pharmaceuticals.
• The integrated workflow empowers non-scientists like law enforcement and border control to make immediate, informed decisions.
• This technology presents a valuable tool for combating the illegal trade of counterfeit medicines at the point of seizure.