SMB as a Development Tool

Preparative chromatography has been used for chiral separations for years, but examples of multi-kg separations (and hence larger ones) were rare until recently. The development of SMB techniques (both hardware and simulation software) has made major breakthroughs in this field. The ability of SMB as a development tool has allowed the pharmaceutical manufacturer to obtain kilo grams quantities of enantiopure drug substances as well benefit from the economics of large-scale production. 

On the other hand, SMB requires strict process control and is less versatile than normal elution chromatography. In that sense, SMB should be viewed predominately as a very powerful tool for production plants, while batch chromatography with its higher flexibility is equally well suited for development purposes. The fact that efficient simulation software is needed to set up an SMB, while an empirical approach is often sufficient for success in batch chromatography points in the same direction. 

Some examples of preparative enantioseparation of chiral drugs are summarized in Table 9. Overall, SMB chromatography is a powerful tool for the production of enantiomerically pure compounds on a large scale within a short phase of development. The availability of software which allows scaling-up of an analytical enantioseparation to SMB technology is a crucial advantage. The characteristics of SMB chromatography are such as to provide pure... 

The use of GC-MS in polymer/additive analysis is now well established. Various GC-based polymer/additive protocols have been developed, embracing HTGC-MS, GC-HRMS and fast GC-MS with a wide variety of front-end devices (SHS, DHS, TD, DSI, LD, Py, SPE, SPME, PTV, etc.). Ionisation modes employed are mainly El, Cl (for gases) and ICPI (for liquid and solid samples). Useful instrumental developments are noticed for TD-GC-MS. GC-SMB-MS is a fast analytical tool as opposed to fast chromatography only [104]. GC-ToFMS is now about to take off. GC-REMPI-MS represents a 3D analytical technique based on compound-selective parameters of retention time, resonance ionisation wavelength and molecular mass [105]. 

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