A CE-based analytical system configured optimally for developing methods for the separation of enantiomers. The system includes a P/ACE MDQ configured with a photo diode array detector, UV source optics, ambient sample storage module and 32 Karat™ Software configured on an IBM personal computer. Installation Qualification, Operation Qualification 1 (OQ1) and documentation to aid in software validation is also included.
Capillary electrophoresis has proven to be the most ideal analytical tool to assess the purity of enantiomers. With this technology it is simple to construct and modify a chiral environment, which is the key to resolving these complex isomers.
The use of cyclodextrins for differential host-guest complexation of enantiomers is by far the most common chiral selector and is the basis of the chiral separation strategy that we propose.
Beckman Coulter's primary strategy focuses on the use highly sulfated cyclodextrins (HSCDs), which are a family of three chiral reagents. This strategy first involves screening the compound for separation using all three (a b and g) HSCDs and then optimizing on the reagent, which yields the best resolution. This initial screen involves the use of a single method and has been successful in greater than 97% of the compounds that Beckman Coulter has analyzed.
Utilizing the following strategy, Beckman Coulter scientists were able to resolve 131 of 135 randomly selected chiral compounds on the initial screen.
The listed file is in PDF format. To view the files, you will need to have the Adobe Acrobat Reader installed on your system. The Acrobat Reader is free and is available for Macintosh, Windows, DOS, Sun, and HP/UX. Information On PDF (Acrobat) Files Distributed on Beckman Coulter Web Server.
To view the files, you will need to have the Adobe Acrobat Reader installed on your system. The Acrobat Reader is free and is available for Macintosh, Windows, DOS, Sun, and HP/UX. Information On PDF (Acrobat) Files Distributed on Beckman Coulter Web Server.
Highly Sulfated Cyclodextrins
The HSCDs are a proprietary distribution of cyclodextrins with an average number of 12 sulfates for the b-CD, 11 for the a-CD and 13 for the g-CD. This distribution was "designed in" to provide increased resolution under defined separation conditions. These products perform well for the analysis of many neutral, basic and weakly acidic compounds of pharmaceutical and biological interest. To ensure batch to batch consistency we have developed a process which generates the final product as a 20% w/v solution of the HSCDs. Our processes in combination with a very rigorous quality control program ensure consistent matching of all lots to a Gold Standard.
Chiral Analysis Methods Development Strategy forEnantiomer Analysis.