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Comparison of Approaches to Determining N-Nitrosodimethylamine Impurity in Valsartan Drug Substance By GC-MS Methods
- Source :
- Pharmaceutical Chemistry Journal. 53:766-770
- Publication Year :
- 2019
- Publisher :
- Springer Science and Business Media LLC, 2019.
-
Abstract
- Methods for determining the genotoxic impurity N-nitrosodimethylamine (NDMA) in valsartan drug substance by gas chromatography (GC) with mass-spectrometric detection in SIM and MRM modes using direct introduction and vapor-phase analysis are compared. The obtained LOQ and DL differed insignificantly. The test results led to the conclusion that use of a method corresponding to the capabilities and equipment of the laboratory was advisable.
- Subjects :
- Pharmacology
Drug
Chromatography
010405 organic chemistry
Chemistry
media_common.quotation_subject
Pharmacology toxicology
01 natural sciences
0104 chemical sciences
010404 medicinal & biomolecular chemistry
chemistry.chemical_compound
Valsartan
Impurity
N-Nitrosodimethylamine
Drug Discovery
medicine
Gas chromatography
Gas chromatography–mass spectrometry
medicine.drug
media_common
Subjects
Details
- ISSN :
- 15739031 and 0091150X
- Volume :
- 53
- Database :
- OpenAIRE
- Journal :
- Pharmaceutical Chemistry Journal
- Accession number :
- edsair.doi...........256181e3ed16347e5a585144caa1e9df