Case Studies in the Application of a Workflow-Based Crystallization Design for Optimized Impurity Rejection in Pharmaceutical Development-Reference-Cited by-同舟云学术

Case Studies in the Application of a Workflow-Based Crystallization Design for Optimized Impurity Rejection in Pharmaceutical Development

Published:2023-03-24 Issue:4 Volume:27 Page:610-626
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Agrawal Paridhi¹^ORCID,Rawal Saurin H.¹^ORCID,Reddy Venkata Ramana¹,Viswanath Shekhar K.¹,Merritt Jeremy M.¹^ORCID

Affiliation:

1. Synthetic Molecule Design and Development, Lilly Research Laboratories, Eli Lilly & Company, 1400 West Raymond Street, Indianapolis, Indiana 46221, United States

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.2c00346

Reference41 articles.

1. Application of Process Analytical Technology-Based Feedback Control Strategies To Improve Purity and Size Distribution in Biopharmaceutical Crystallization

2. Recent Developments in the Crystallization Process: Toward the Pharmaceutical Industry

3. ICH Harmonised Tripartite Guideline Impurities in new drug substances Q3A (R2). Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; Citeseer: Geneva, Switzerland, 2006; Vol. 25.

4. ICH Harmonised Tripartite Guideline. current step. Impurities in New Drug Products, 2006; Vol. 4, pp 1–5.

5. Overview of Genotoxic Impurities in Pharmaceutical Development

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