NMR under GxP in Drug Development Manufacturing
This paper, in conjunction with Bruker BioSpin, summarises multiple examples of where NMR is used in regulated environments (i.e. GLP and GMP: known as GxP) and describes how the technique adds value during various stages in the progression of compounds from research, via development and then into commercial manufacturing.
A series of examples are described in detail, with the target species being classical small molecule drugs or biopharmaceuticals. The NMR experiments used in these analyses range from the ubiquitous 1D characterisation (1H or 13C) through to more complex experiments including 2D e.g. 1H-1H COSY, 1H-13CHSQC and 1H-13C HMBC. Overall, it is clear that NMR is used widely under GxP and is an important technique that supports drug research, development and manufacturing.
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