Development of a Control Strategy for a Final Intermediate to Enable Impurities Control
This manuscript describes the development of a control strategy for impurities in the final intermediate step of the asunaprevir drug substance utilizing the concepts outlined in the International Conference on Harmonisation guidelines.
Unit Operation: Reaction
Objective: Design, Kinetics
Company: BMS
Source: Org. Process Res. Dev., 2016, 20 (10), pp 1781–1791
Authors: Nathan R. Domagalski (BMS), Michaël D. B. Fenster (BMS), Daniel Hallow (BMS), Lindsay Hobson (BMS), Sha Lou (BMS), Antonio Ramirez (BMS), Sushil Srivastava (BMS), Srinivas Tummala (BMS)
Publish Date: 07-Oct-2016
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