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Quantification in Solid Mixtures A Benchtop Solution for the Analysis of API and Drug Product Quantification of components in complex solid mixtures like formulated pharmaceuticals (drug product) is crucial for the pharmaceutical industry and generally in materials science.1 However, the quantification of relative amounts of API polymorphs and the corresponding amorphous forms in the presence of excipients is not a straighforward proposition. Current methods include spectroscopic, thermometric and x-ray techniques and often require laborious calibrations, are expensive or may lack the required accuracy. Designed to overcome these obstacles, Bruker’s new solution enables easy and affordable quantification of API polymorphs, drug loading and amorphous content in solid mixtures. The required instrument is a benchtop time-domain NMR (TD-NMR), which can be deployed either in a laboratory or a production environment. Quantification by TD-NMR Benefits Uses a benchtop instrument: versatile, portable, cryogen-free, small foot print, affordable and with low maintenance costs Minimal sample preparation: solid samples are placed into the glass tube Non-destructive technique: samples can be re-analyzed or re-used for other purposes High accuracy when sufficient signal to noise ratio Selective, specially when observing 19 F, which is typically not present in excipients Push-button acquisition Fast and easy calibration Complete workflow from data acquisition to project report with ability to export data in other formats for additional processing Stueber D. and Jehle S., Anal Chem, submitted 1 Innovation with Integrity NMR The new method uses 1H and 19F T1 saturation recovery curves (SRCs) measured on a Bruker minispec mq20 benchtop TD-NMR instrument. For the analysis of a given mixture, the SRCs for the relevant pure components, as well as for the mixture itself, are measured. The relative amounts of the mixture components are obtained from a fit of the mixture SRC with a linear combination of weighted pure component SRCs. For a two components the equations is shown below. © Bruker BioSpin 09/16 T161810 Where I is the intensity of the mixture, compound 1 and compound 2 at each recovery time point . S1 and S2 are scaling factors which take into account number of protons, molecular masses and plateau values of the SRC curves. Modeling the mixture data yields the concentration C1 and C2. Bruker BioSpin [email protected] www.bruker.com