Application Note: Handheld Near-Infrared Spectroscopy Used As An Authentication Technology For Pharmaceuticals

By F. G. Haibach

Near infrared diffuse reflectance is a rapid, non-invasive method of investigating pharmaceutical raw materials and finished forms. The use of near-infrared to distinguish placebo and active formulations is over 15 years old. It is not surprising that in early 2001 a few independent groups presented results for counterfeit identification.

Handheld spectrometers allow the use of benchtop-like tools in the field. Screening for authentic and counterfeits is rapid and forensic investigations are facilitated by timely results. Specificity is excellent; authentic pharmaceutical tablets can be readily distinguished from counterfeits.

According to the World Health Organization IMPACT, a counterfeit pharmaceutical is, "a medicine, which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging."

Development and updating of the analysis, a PCA model, is extremely rapid. Polychromix provides a software package that allows for rapid development and validation of created methods.