Raman and IR Spectroscopy Identifies Counterfeit Drugs

Have you ever bought counterfeit foods, drugs or supplements? How would you know?

The U.S. Food and Drug Administration wants to eradicate this counterfeit goods problem. Raman spectroscopy plays an important role in identifying these phony substances.

Shady suppliers will counterfeit expensive drugs because of its economic value. That includes lifestyle drugs like Viagra, Cialis, Lipitor, or vital drugs like Hyzaar, a blood pressure medication, Tamiflu, a vaccine for influenza, and Plavix, a blood thinner. Selling imitations of these drugs can earn someone a substantial profit.

Food tampering occurs often with baby formula. The formula, as many parents know, is expensive. Sometimes individuals will buy the formula and remove it from its packaging. They then replace it with another substance, like flour, and take it back to the store for a refund. The formula ends up back on the shelf. Some people have also substituted Tylenol in the same way.

Investigators also commonly target dietary supplements. There are many examples of supplements that claim weight loss and properties for treating erectile dysfunction. Those products might contain drug substances instead of the advertised natural products.

The FDA’s Trace Examination Section of its Forensic Chemistry Center is responsible for examining the legitimacy of these items. The FDA also has a law enforcement branch called the Office of Criminal Investigations, which probes criminal activities. It provides the Trace Examination Section with samples from its investigations into counterfeit or tainted drugs and other substances for analysis.

The Trace Examination Section uses Raman spectroscopy for counterfeit and unknown particle analysis.

Investigators sometimes use a combination of infrared spectroscopy and Raman spectroscopy to identify different components used to make a prescription tablet. The methods tell researchers what is in the tablet. Investigators compare it to an authentic product to show whether the legitimate manufacturer made it.

Raman has its advantages. It’s a non-destructive technique and preserves the evidence. It also allows investigators to analyze very small particles. Raman lets investigators analyze some particles that infrared spectroscopy can’t because of its size.

The FDA’s Trace Examination Section uses a HORIBA LabRAM IR², a micro-Raman spectrometer, to identify the particles. The instrument includes infrared spectroscopy capabilities. The lab also has a HORIBA’s XploRA PLUS, a Raman spectrometer with intelligent sampling automation, called the ParticleFinder^TM module.

ParticleFinder provides investigators with several advantages. Traditional Raman microscopy can be time-consuming. An investigator has to scan the substance one section at a time, over the entire sectioned area. The ParticleFinder application helps survey a large particle field very rapidly by automatically locating, then doing Raman analysis on select particles only. That way, investigators can use the chemical information derived from that analysis with the optical microscopy to determine the amount of unknown particles in a particular sample.

Armed with Raman and infrared spectroscopy, the FDA, through its Trace Examination Section, can identify distributors of counterfeit foods, drugs, and supplements.