Automated method for estimating the degradation of an active substance

Abstract

The present solution consists of a method that allows the determination of the quantity and content uniformity of an active ingredient in a pharmaceutical formulation. This method involves reading the infrared spectroscopic signal of the active ingredient, preferably using a quantum cascade laser (QCL), although other spectroscopic techniques are also valid. The spectroscopic data obtained is analyzed through a multivariable analysis model using partial least squares (PLS), which is then used to train an artificial intelligence system. This trained AI is capable of determining the concentration of the active ingredient in the pharmaceutical formulation. By taking measurements at different physical points in the formulation, it is also possible to determine the distribution of the active ingredient within the formulation, and therefore, its uniformity.

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