Work

Impurity Qualification Thresholds: An IQ Survey on Emerging Industry Experience with Health Authority Feedback

Year: 2025

Type: article

Study design: Observational Study

Source: Organic Process Research & Development

DOI: 10.1021/acs.oprd.5c00300

Authors: Jennifer Alleva, Kate Arnot, Elizabeth A. Martin, Alejandra Trejo-Martin, John Nicolette, Mayur S. Mitra, Teresa Wegesser, Kaushik Datta, Sathanandam S. Anand, Joel Bercu

Institutions: Gilead Sciences (United States), AstraZeneca (United Kingdom), Johnson & Johnson (United States), Genentech, Amgen (United States), Bristol-Myers Squibb (United States), Boehringer Ingelheim (Germany), Boehringer Ingelheim (United States)

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: closed

OpenAlex ID: W4415570709

FWCI:

Cites: 13

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