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 spectroscopy measurement method was included in the seventeenth revision of the Japanese Pharmacopoeia, second supplement, increasing expectations for Raman spectroscopy. It has become a widely used analytical method, ranging from the evaluation of the crystal forms of active pharmaceutical ingredients and research and development of crystallization reactions to quality control such as the assessment of content uniformity of active ingredients in formulations and raw material acceptance testing. As its use has expanded, issues have also emerged, such as the spectral tilting of substances with fluorescence, including 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 errors in pharmaceutical quality control. Therefore, using crystalline cellulose with fluorescence 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.

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