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European Biopharmaceutical Review

Integrated Spectroscopy

In service laboratories in the pharma industry today, chemists synthesise huge numbers of different compounds on the basis of parallel synthesis and combinatorial chemistry, which must be verified. One main aspect is the confirmation of chemical identity and information about molecular formulae to identify possibly present impurities.

Most often, a screening approach is applied in order to obtain a rough estimation on the purity, concentration and identity of the synthesised products. This flags up samples below a certain purity or those with too many impurities or samples that are not what they are considered to be. It is often impossible to use all samples at the same time; therefore most of the samples are stored in libraries for later use. Undertaking quality control on a regular basis is mandatory in order to check for possible degradation reactions.

The main application areas for quality control and confirmation of molecular ID is synthetic chemistry (medicinal chemistry, core facility, organic chemistry and pharma NCE). Another broad field of application is the identification of small molecules, such as metabolite ID, natural products and pharma impurity.

All of these issues are handled using different spectroscopic techniques (such as NMR, LC-MS and X-ray) and by manual inspection of all the spectra types generated. This activity demands an expensive reservoir of human experts with vast knowledge in spectral interpretation; a talent that is becoming very rare nowadays. It also is very cost-intensive, which is why the quality assurance of larger libraries was often neglected in the past, and only rudimentary analysis was performed on select samples. An automated approach to structure verification based on the integration of different information rich spectroscopic methods should be the method of choice.

COMPLETE MOLECULAR CONFIDENCE

Complete molecular confidence (CMC) is a concept for a fully-integrated NMR/LC-MS based solution optimally complemented by X-ray spectroscopy, supporting molecular formulae determination and automated structure verification...

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Dr Ulrich Braumann studied chemistry at the University of Tьbingen at the Institute of Organic Chemistry. He finished his studies at this university with his doctoral thesis in 1995. He started working at Bruker in 1995 in the field of LC-NMR where he is now responsible for application field flow-NMR as Product Manager.

Dr Herbert Thiele was educated at the Institute of Organic Chemistry, TH Aachen, where he gained his diploma and wrote his doctoral thesis. He started out in 1977 as a teacher of Chemistry and Mathematics at the Fachschule des Heeres fьr Technik/ Aachen. He joined Bruker in 1978 and has held various management positions, as well as being made an Honorary Professor in Analytical Chemistry at the University of Bremen. In 2002 he was appointed Director of Bioinformatics. Email: ht@bdal.de

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Dr Ulrich Braumann
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Dr Herbert Thiele
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