499257 Removal of Impurity from API and Reduction of Agglomeration during Drying

Onkar Manjrekar1, Howard E. Morton2, Jie Chen1, Lijie Cui3, David Barnes3, Jose Napolitano3, Jeff Hartnell3, Jeff Bien4, Elie Chaaya5, Subramanya Nayak6 and Shailendra Bordawekar7, (1)Process Research and Development, AbbVie, North Chicago, IL, (2)GPRD Process R&D, AbbVie, North Chicago, IL, (3)AbbVie, North Chicago, IL, (4)AnnVie, North Chicago, IL, (5)Merck & Co. Inc., Rahway, NJ, (6)AbbVie, (7)Process Research and Development, AbbVie Inc., North Chicago, IL

In this work we describe removal of an impurity from an API which was not detected in HPLC and can be observed only in NMR in specific solvents. A kinetic model was developed for conversion of this impurity to API using online NMR. Based on the prediction from the model the impurity was converted into API and isolated after crystallization. There were challenges in milling of the API due to large chunks (about 1 -2 cm) which were formed due to agglomeration during filtration and drying. This issue was resolved by using filter dryer, application controlled vacuum and application of agitation in the filter dryer based on LOD of the API during drying.

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