Research on Chemical Intermediates p. 267 - 281 (2020)
Update date:2022-08-28
Topics:
Girigani, Sathyanarayana
Singh, Harnam
Kola, Sankar Rao
Dayanand Yelmeli, Vijayalaxmi
Regula, Venu Gopal
Shah, Sakshi
Jain, Neelu
Kumar, Pramod
A robust and safe industrial process, including five isolations and drying steps for widely prescribed anti-HIV (protease inhibitor) drug darunavir ethanolate 2, has been developed. A salient feature of this process is the development of procedures enabling the efficient synthesis of multi-kilogram quantity of darunavir ethanolate, and process demonstrations through plant scale preparation are offered where darunavir molecule has been prepared with overall > 70% chemical yield and > 99.8% purity without involving any purification procedure(s), with all possible process impurities below than the desired limit (not more than 0.08%) were isolated, synthesized and characterized. The developed process is entirely robust, very efficient and demonstrated up to kilograms scale.
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