Quantification is required in the drug research, development, and manufacturing. Through drug development, analytical methods to quantify potency/purity of drug candidates and their reference standards as well as to quantify the level of impurities in those drugs are developed. Ideal techniques are non-destructive, accurate and robust without the need for extensive sample preparation, method development or complex calibrations.
Inherently quantitative, NMR and EPR enable rapid and straightforward quantification of solids and liquids without the need of method development or response factor calculations. Hence the broad applicability of quantitative NMR (qNMR). Bruker has a suite of tools designed to simplify your workflow and enhance your productivity whether you need to check the concentration of ligands for screening, measure the potency of APIs, determine in-situ yields, quantify polymorph and amorphous form, polysorbates or check the filling of your vials and syringes.
New tools for Data Integrity (DI), compliance and good laboratory and manufacturing practices.
Analysis of Shelf-Life of Polysorbates by Electron
Paramagnetic Resonance (EPR) Spectroscopy in 60 min –Impact in Biologics’ Development