Development of a continuous synthesis process for carbamazepine using validated in-line Raman spectroscopy and kinetic modelling for disturbance simulation-Reference-Cited by-同舟云学术

Development of a continuous synthesis process for carbamazepine using validated in-line Raman spectroscopy and kinetic modelling for disturbance simulation

Published:2023 Issue:5 Volume:8 Page:1032-1042
ISSN:2058-9883
Container-title:Reaction Chemistry & Engineering
language:en
Short-container-title:React. Chem. Eng.

Author:

Glace Matthew¹^ORCID,Wu Wei¹^ORCID,Kraus Harrison¹,Acevedo David²,Roper Thomas D.³^ORCID,Mohammad Adil¹^ORCID

Affiliation:

1. Division of Product Quality Research, Office of Testing and Research Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA

2. Division of Pharmaceutical Manufacturing Assessment I, Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA

3. Department of Chemical and Life Sciences Engineering, Virginia Commonwealth University, Richmond, VA 23284, USA

Abstract

Mitigation of failure modes in the continuous synthesis (CS) of a drug substance (DS) has the potential to widen the adoption of continuous manufacturing (CM) technologies by the pharmaceutical industry.

Funder

Oak Ridge Institute for Science and Education

Publisher

Royal Society of Chemistry (RSC)

Subject

Fluid Flow and Transfer Processes,Process Chemistry and Technology,Chemical Engineering (miscellaneous),Chemistry (miscellaneous),Catalysis

Link

http://pubs.rsc.org/en/content/articlepdf/2023/RE/D2RE00476C

Reference35 articles.

1. Department of Health and Human Services, Food and Drug Administration , Guidance for Industry , 2004

2. A Perspective on Continuous Flow Chemistry in the Pharmaceutical Industry

3. International Council of Harmonization , ICH Q13 Guidance, 2021