Synthesis and analysis of isotopically stable labeled nitrosamines as mass spectrometry standards for drug impurity quality control-Reference-Cited by-同舟云学术

Synthesis and analysis of isotopically stable labeled nitrosamines as mass spectrometry standards for drug impurity quality control

Published:2023-01-05 Issue:2 Volume:66 Page:41-46
ISSN:0362-4803
Container-title:Journal of Labelled Compounds and Radiopharmaceuticals
language:en
Short-container-title:Labelled Comp Radiopharmac

Author:

Derdau Volker¹^ORCID,Sandvoss Martin¹

Affiliation:

1. Sanofi Germany, R&D, Integrated Drug Discovery, Isotope Chemistry Industriepark Höchst Frankfurt am Main Germany

Publisher

Wiley

Subject

Organic Chemistry,Spectroscopy,Drug Discovery,Radiology, Nuclear Medicine and imaging,Biochemistry,Analytical Chemistry

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jlcr.4010

Reference35 articles.

1. https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-information-nitrosamines-marketing-authorisation-holders_en.pdf

2. A side reaction may have led to impurities found in valsartan heart drugs T. Nguyen in C&EN Chemical engineering news; Feb 19 2019.https://cen.acs.org/pharmaceuticals/process-chemistry/side-reaction-led-impurities-found/97/web/2019/02

3. EMA homepage.https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities

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