Establishing Best Practice for the Application and Support of Solubility Purge Factors-Reference-Cited by-同舟云学术

Establishing Best Practice for the Application and Support of Solubility Purge Factors

Published:2023-03-14 Issue:10 Volume:27 Page:1751-1758
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Burns Michael J.¹^ORCID,Andrews Ian X.²,Baumann Jens-Christoph³,Elliott Eric L.⁴,Fennell Jared W.⁵^ORCID,Kallemeyn Jeffrey M.⁶^ORCID,Lemaire Sebastien⁷^ORCID,Murphy Natasha S.¹,Palacio Magali⁸,Raw Steven A.⁹^ORCID,Roberts Alastair J.¹⁰,Moura Rocha Nayrton Flávio¹¹,Schils Didier¹²,Oestrich Rolf Schulte³,Shannon-Little Andrew L.¹^ORCID,Stevenson Neil¹³,Talavera Pere¹⁴,Teasdale Andrew⁹,Urquhart Michael W.¹⁰^ORCID,Waechter Fernanda¹

Affiliation:

1. Lhasa Limited, Leeds LS1 5PS, West Yorkshire, United Kingdom

2. GlaxoSmithKline, Collegeville, Pennsylvania 19426, United States

3. F. Hoffmann-La Roche Ltd., Basel CH-4070, Switzerland

4. Takeda Pharmaceuticals, Cambridge, Massachusetts 02139, United States

5. Eli Lilly and Co., Indianapolis, Indiana 46285, United States

6. AbbVie, North Chicago, Illinois 60064, United States

7. Johnson & Johnson Pharmaceutical Research and Development, 2340 Beerse, Belgium

8. UCB Pharma, 1420 Braine l’Alleud, Belgium

9. Pharmaceutical Technology and Development, AstraZeneca, Macclesfield Campus, Charter Way, Macclesfield, Cheshire SK10 2NA, United Kingdom

10. GlaxoSmithKline, Stevenage SG1 2NY, Hertfordshire, United Kingdom

11. Brazilian Health Regulatory Agency, ANVISA, Brasilia 71205-050, Brazil

12. iTeos Therapeutics, 6041 Gosselies, Belgium

13. Benevolent AI, London W1T 5HD, United Kingdom

14. Esteve Química, 08030 Barcelona, Spain

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.2c00360

Reference22 articles.

1. Genotoxic Impurities: From Structural Alerts to Qualification

2. Is Avoidance of Genotoxic Intermediates/Impurities Tenable for Complex, Multistep Syntheses?

3. ICH Guideline M7 - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk - Scientific Guideline; ICH, 2014. https://www.ema.europa.eu/en/ich-m7-assessment-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit-potential.

4. A Tool for the Semiquantitative Assessment of Potentially Genotoxic Impurity (PGI) Carryover into API Using Physicochemical Parameters and Process Conditions

5. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control

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