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