Comparison of Approaches to Determining N-Nitrosodimethylamine Impurity in Valsartan Drug Substance By GC-MS Methods

Comparison of Approaches to Determining N-Nitrosodimethylamine Impurity in Valsartan Drug Substance By GC-MS Methods

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 insignificantl...

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Veröffentlicht in:Pharmaceutical chemistry journal 2019-11, Vol.53 (8), p.766-770
Hauptverfasser: Khorol’skii, M. D., Anan’ina, O. V., Chaplenko, A. A., Nedkov, I. V., Maslennikova, N. V., Ramenskaya, G. V.
Format: Artikel
Sprache:eng
Schlagworte:
Medicine
Methods
Multiple sclerosis
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
Valsartan
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Zusammenfassung: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.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-019-02076-y