Impurity Profiling for a Scalable Continuous Synthesis and Crystallization of Carbamazepine Drug Substance-Reference-Cited by-同舟云学术

Impurity Profiling for a Scalable Continuous Synthesis and Crystallization of Carbamazepine Drug Substance

Published:2024-05-01 Issue:5 Volume:28 Page:2013-2027
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Glace Matthew¹,Kraus Harrison¹²,Wu Wei¹^ORCID,Acevedo David³^ORCID,Liu Dongxia²⁴^ORCID,Roper Thomas D.⁵^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, Maryland 20993, United States

2. Department of Chemical and Biomolecular Engineering, University of Maryland, College Park, Maryland 20742, United States

3. 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, Maryland 20993, United States

4. Department of Chemical and Bimolecular Engineering, University of Delaware, Newark, Delaware 19716, United States

5. Department of Chemical and Life Sciences Engineering, Virginia Commonwealth University, Richmond, Virginia 23284, United States

Funder

Oak Ridge Institute for Science and Education

Center for Drug Evaluation and Research

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.4c00081

Reference52 articles.

1. Carbamazepine

2. Aquatic risks from human pharmaceuticals—modelling temporal trends of carbamazepine and ciprofloxacin at the global scale

3. Ansari, S. A.; Bhat, R.; Kulkarni, A. K. Process for the Preparation of 10-Methoxycarbamazepine. European Patent EP 1 302 464 A1 2003.

4. Karusala, N. R.; Tummalapalaly, U. S.; Talatala, A. An Improved Process for the Synthesis of Oxycarbamazepine. International Patent 2009, WO 2009/139001, A2.

5. Karusala, N.; Tummalapally, S.; Talatala, A.; Datta, D. Process for the Preparation of Oxycarbamazepine. US Patent 2013, 8,530,647 B2.

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