Journal
ORGANIC PROCESS RESEARCH & DEVELOPMENT
Volume 20, Issue 8, Pages 1509-1519Publisher
AMER CHEMICAL SOC
DOI: 10.1021/acs.oprd.6b00208
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The development work toward the robust and efficient manufacturing process to vismodegib, the active pharmaceutical ingredient (API) in Erivedge, is described. The,optimization of the four-stage manufacturing process was designed to produce the API with the required critical quality attributes: (1) the selective catalytic hydrogenation reduction of the nitro compound 3 to the corresponding aniline 4 while minimizing the formation of potential genotoxic (mutagenic) impurities; (2) the control of the polymorphic phase and multipoint specification for particle size distribution.
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