Reliable drug quality tests are essential for ensuring the health of consumers of farmaceutical preparations. Legally binding instructions for quality tests have been complied into the so called Pharmacopeias, which tends to be specific for each country. Most of the methods for qualitative and quantitative caracterization described are derived from quality control methods that were already used by the industry. Therefore, when those methods use equipments, they use equipment that was readily availble, mainly cromatography.
Over the past decades the demand for quality control has increased a lot, whereas the methods have remained unchanged. In some cases the Pharmacopeia method takes 2 days until delivering the result, making it difficult to keep up with the increasing demand. Motivated by this bottleneck (among other reasons), in 2016 ANVISA (the brazilian FDA) has initiated an effort to include Nuclear Magnetic Ressonance (NMR) into the brazilian Pharmacopeia.
In the present study we have put together a set of NMR methods for qualification and quantification of farmaceutical preparations. Together with the Instituto Nacional de Controle de Qualidade em Saúde (INCQS) we have selected we have selected 11 reference drugs, which we then run through the NMR methods for quantification and compared the results to Pharmacopeia methods, as executed by INCQS. Afterwards we have explored the use of software for metabolomics in order to automatically qualify and quantify our samples.