首页|Development of an impurity and hydrate form controlling continuous crystallization to telescope a two-step batch recrystallization in the GDC-4379 drug substance process
Development of an impurity and hydrate form controlling continuous crystallization to telescope a two-step batch recrystallization in the GDC-4379 drug substance process
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The development of an impurity and form controlling continuous crystallization process to deliver the JAK1 inhibitor GDC-4379 is described.Explored as a next generation process for the two-step batch recrystallization procedure used in production,the translation of the impurity control step to a continuous mixed suspension,mixed product removal(MSMPR)crystallizer enabled superior kinetic rejection of a key regioisomer impurity(97.9%)versus the batch process(32.4%).By operating the MSMPR crystallizer at sufficient water content and temperature it was verified that the target hydrate form A of GDC-4379 for the active pharmaceutical ingredient(API)could be selectively crystallized from the DMSO/MeOH solvent system of the purification step.This demonstration provided proof of concept for a telescoped continuous crystallization process for GDC-4379 to replace the separate batch impurity and form control recrystallizations carried out in production.
Continuous crystallizationActive pharmaceutical ingredient(API)Mixed suspension,mixed productremoval(MSMPR)crystallizerImpurity rejectionHydrate form controlProcess telescoping
Gary Morris、Aaron P.Keogh、Umar Farid
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Engineering,APC Ltd.,Building 11,Cherrywood Business Park,Loughlinstown,Co.Dublin,Ireland
Chemistry,APC Ltd.,Building 11,Cherrywood Business Park,Loughlinstown,Co.Dublin,Ireland
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