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Process Chemistry News

Sulfonate Salts of APIs

Written by Dr Will Watson on Monday, 11 May 2015. Posted in Latest News

Sulfonate salts have had a very bad press in recent years, because they are often prepared in alcoholic solvents which potentially creates problems with the formation of alkyl sulphonates which are potentially genotoxic impurities.

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Appearing and Disappearing Polymorphs

Written by Dr Will Watson on Friday, 13 February 2015. Posted in Process Chemistry News

Dr Trevor Laird (Scientific Update) talked about appearing and disappearing polymorphs and other solid forms in process development, during the '2nd Winter Process Chemistry' Conference in December. This involved a number of case studies including axitinib, Pfizer's anti-cancer drug, has 5 anhydrous forms and over 70 different solvates known to date and requires a complex crystallisation wash procedure to obtain the correct form. In another example from Merck-Schering Plough batches from one reactor train started to fail because of a yellow colouration. Product from an older reactor train did not have this problem. Temperature and humidity, particularly during drying were found to be critical. During drying a new anhydrate was being formed which then formed a new hydrate when exposed to moist air. The new hydrate is unstable forming the yellow impurity. The problem was solved by a modified wash and drying sequence.

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Scientific Update, established in 1989 by Dr. Trevor Laird, organises conferences and training courses for industrial chemists and chemical engineers in chemical development and scale-up and many other specialist topics in organic chemistry. We also provide extensive consultancy services in these fields and edit the international scientific journal entitled Organic Process Research and Development (OPRD).

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