Our client, a leading pharmaceutical company, was in urgent need of 14 characterized standards of by-product for their registration and for the transfer of the production process to a new overseas production site. Some of the by-products were not available, others only in small quantities of unknown quality. No synthetic routes were available for the re-synthesis of the missing samples.

CarboGen and AMCIS prepared a plan for the synthesis and the caracterization of the by-products as primary reference standards according to GLP. The chemical structures of the already-available materials were confirmed by NMR and mass spectrometry. Simultaneously our synthesis department prepared 10 g samples of each by-product and an analytical HPLC method was developed for the determination of all 14 by-products.

Within the given timeframe, CarboGen and AMCIS provided certified material along with synthesis and purification reports, GLP study reports and an analytical HPLC method for all by-product-standards. Today, we provide full Standard Management for our customer including storage in our GLP storage facilities, periodic re-analysis and on-request shipment.