Verification for the improvement of the accuracy of identity testing.

Confirmation test

In May 2014, Japan's membership in PIC/S was approved, leading to the consideration of operational verification tests for all pharmaceutical raw materials used in formulations as required by PIC/S. Furthermore, in 2019, the Raman spectral measurement method was included in the seventeenth revision of the Japanese Pharmacopoeia, second supplement, increasing expectations for Raman spectroscopy. This analytical method has become widely used, ranging from the evaluation of the crystal forms of active pharmaceutical ingredients and research and development of crystallization reactions to quality control measures such as the assessment of content uniformity of active ingredients in formulations and raw material acceptance testing. As its use has expanded, issues have emerged, such as the spectral shifts of fluorescent substances like cellulose and herbal raw materials. In recent years, cases of counterfeit pharmaceuticals have come to light, raising questions about the scientific validation of testing methods and the minimization of human error in pharmaceutical quality control. Therefore, using crystalline cellulose with fluorescent properties as a model raw material, we report the results of constructing a discrimination model using a portable Raman spectrometer and scientifically validating the variability of the discrimination model and test results.

Spectroscopic Analysis Equipment