Quantitative analysis using near infrared spectroscopy, application to tablet content uniformity test, II

The first part of this article [1] described the methodology to follow to develop a technique for the quantitative analysis of active substance in a solid tablet type formulation using near infrared spectroscopy. It seems appropriate to complete this description by detailing the different steps involved through illustrated examples and by proposing useful guidelines for new users. The quantitative analysis example chosen is that of content uniformity (CU) of tablet type solid forms (cf. Ph. Eur. 2.9.6/2.9.40) [2], a test required in the pharmaceutical industry and for which this alternative quantitative analysis could offer substantial gains. It should be noted that the approach described applies to other types of quantitative analysis (mean assay, water content in raw materials, polymorph assay within a tablet, etc.).