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