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Case Study: Polymorph C i i ( H l Collaborator: Mid-size biotech company

Object ive: To scale up and manufacture 1.5 kg of a NCE mesylate salt to support toxicology and Phase I clinical trials.

I Details: Mesylate salt process developed by customer at a third party provider. Mesylate had desirable solubility

„.' ;„ /andxrfystaJIrnity but the final process did not control for two identified polymorphic forms. Salt formation conditions

utilizedMeOH, which has potential to form methyl mesylate alkylating agent (MMAA).

r ; Results: Utilizing our crystallization screening platform, AMRI's physical chemists delivered the following:

•v: Developed conditions that selectively provided the desired polymorph.

im&Mdldi riewprocedure that eliminated the potential for MMAA formation.

palemp^flhe^ oewprocedure afforded reproducible production of the mesylate

^^^^^^^^^^^iihmXSfio weeks and production timelines were maintained. ^ • f e £ | *^g)ls£r*z. •

XI Albany Molecular Research. Inc 21 Corporate Circle, P.O. Box 15098 • Albany, NY 12212-5091 V§{ Phone:518-464-0279 • Fax:518-464-0289 • www.albmolecular.coni - ,-

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