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Development and Scale-Up of a Continuous Manufacturing Process for a Hydrazine Condensation Reaction

By Zhu, Ruiheng; Reddy, Ramesh; Ding, Man; Xu, Ming; Deng, Chaoyi; Tadayon, Sam; Li, Hui; Depew, Kristopher; Lane, Benjamin

Published on

Abstract

The development of a continuous manufacturing process for a hydrazine condensation reaction at high temperature is reported. This continuous process represents a safer approach to manufacture 3-phenyl-1H-pyrazol-5-amine at scale and exhibits better impurity control compared to a traditional batch process. A controlled crystallization allowed consistently low levels of residual hydrazine (<20 ppm) in isolated solids for further processing to final drug substance. The scalability and robustness of the continuous process was demonstrated at 3 kg scale with a throughput of 0.5 kg/h.

Journal

Organic Process Research & Development. Volume 25, 2021, 199–205

DOI

10.1021/acs.oprd.0c00424

Type of publication

Peer-reviewed journal

Affiliations

  • Shanghai SynTheAll Pharmaceutical Company Limited (“STA”)
  • Agios Pharmaceuticals, Inc.

Article Classification

Research Article

Classification Areas

  • Intermediate

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