Verification of the identity of pharmaceutical substances with near-infrared spectroscopy

It has been investigated whether NIRS can be applied as a stand-alone method for verifying the identity of pharmaceutical substances in a pharmaceutical setting, what the minimum requirements are, and how these methods should be validated. Concluded is that NIRS is acceptable as stand-alone method. However, the requirements are a careful construction of the spectral library and development, validation and maintenance of the method. To validate the specificity and reliability, such NIRS methods should be challenged with a rationally composed set of other substances. The use of the chemometric algorithms 'wavelength correlation' and 'maximum wavelength distance', that are based on standard mathematical formulae, applied on the whole near-infrared range (1000 - 2500 nm) is preferred. Additional guidance is provided in this report. This can be used by both the pharmaceutical industry and competent authorities. It has already been used to formulate an European draft guideline that covers the application of NIRS in the pharmaceutical industry