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Analytical Method Development Strategy for Controlling Two New Nitrosamine Drug Substance Related Impurities (NDSRIs) in a Pharmaceutical Drug Product for Treatment of a Rare Disease

Crossref DOI link: https://doi.org/10.1007/s10337-025-04405-8

Published Online: 2025-03-24

Published Print: 2025-05

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Mukherjee, Partha

Yao, Xin

Brignol, Nastry

Chao, Madison

Tuske, Steven

Sheikh, M. Osman

Brudvig, Jon

Sitaraman, Sheela

Weimer, Jill M.

Ramdas, Saroj
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Text and Data Mining valid from 2025-03-24

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Article History

Received: 14 January 2025

Revised: 2 March 2025

Accepted: 11 March 2025

First Online: 24 March 2025

Declarations

:

: The authors declare no competing interests.

: Partha Mukherjee, Xin Yao, Steven Tuske, M. Osman Sheikh, Nastry Brignol, Jon Brudvig, Madison Chao, Saroj Ramdas, Sheela Sitaraman, and Jill Weimer report relationships with Amicus Therapeutics that include employment and equity or stocks.

: There are no patents to disclose.

: There are no additional activities to disclose.

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