N-Nitrosamines Impurities in Pharmaceuticals The Abrupt Challenges that Resulted, the Evolving Science, and the Regulatory Framework
J Pharm Sci
.
2023 May;112(5):1161-1162.
doi: 10.1016/j.xphs.2023.01.016.
Epub 2023 Jan 24.
Authors
Justin Moser
1
,
Jörg Schlingemann
2
,
Christoph Saal
3
Affiliations
1
Merck & Co., Inc. 770 Sumneytown Pike WP78-110 West Point, Pa 19486, United States of America.
2
Merck Healthcare KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany.
3
Merck KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany. Electronic address: christoph.saal@gmx.de.
PMID:
36706836
DOI:
10.1016/j.xphs.2023.01.016
No abstract available
Publication types
Editorial
MeSH terms
Drug Contamination
Nitrosamines*
Pharmaceutical Preparations
Substances
Nitrosamines
Pharmaceutical Preparations