Application of mid-infrared spectroscopy to the development and transfer of a manufacturing process for an active pharmaceutical ingredient.

The use of in situ mid-infrared spectroscopy to support the development of a pharmaceutical manufacturing process is disclosed. Data on this two-stage telescoped reaction from several reaction scales (<50 mL to 1600 liters) and at multiple manufacturing locations is shown. In addition to providing data on both reactions in the telescope, the mid-IR data has been used to monitor an intermediate distillation operation and therefore it has been possible to profile the whole process.

Multivariate statistical analysis of Raman images of a pharmaceutical tablet.

This paper describes the application of principal component analysis (PCA) and independent component analysis (ICA) to identify the reference spectra of a pharmaceutical tablet's constituent compounds from Raman spectroscopic data. The analysis shows, first with a simulated data set and then with data collected from a pharmaceutical tablet, that both PCA and ICA are able to identify most of the features present in the reference spectra of the constituent compounds. However, the results suggest that the ICA method may be more appropriate when attempting to identify unknown reference spectra from a sample.

In situ Raman spectroscopy: a process analytical technology tool to monitor a de-protection reaction carried out in aqueous solution.

The application of in situ Raman spectroscopy at small scale (maximum 80 mL) during the development of a manufacturing process is disclosed. The reaction was run in aqueous solution between ambient and 100 °C. Raman spectroscopy has proven to be a viable method to track the reaction.