Raman Spectroscopy: A Sensitive and Specific Technique for Determining the Accuracy of Compounded Pharmaceutical Formulations.

OBJECTIVES: Raman spectroscopy is a widely used technology to identify chemical unknowns or confirm chemical identity. We have tested Raman spectrometry to identify compounded pharmaceutical formulations. In contrast to the commonly used application mentioned above, compounded pharmaceutical formulations contain a mixture of ingredients, and the Raman spectrometer is being used to correctly identify the composition of the complete pharmaceutical formulation, including the active pharmaceutical ingredient(s). The objective of this pilot study was to document the potential use of Raman spectroscopy as a tool to provide quality control to compounded pharmaceutical formulations. METHODS: "Testing a test" study design was used to prospectively determine whether Raman spectroscopy could verify the accuracy of compounded pharmaceutical formulations. A total of 9 formulations that are commonly compounded at Cook Children's Health Center were selected for testing. Each of the 9 formulations and 2 blank controls were randomly tested for compounding accuracy in replicate. A total of 110 tests were conducted. RESULTS: Raman spectroscopy was found to be a reliable test to determine the accuracy of compounded pharmaceutical formulations with a 100% positive predictive value. CONCLUSIONS: Raman spectroscopy promises to be an excellent tool for compounding pharmacies to provide an objective measure of compounding accuracy to their unique, compounded pharmaceutical formulations.