Email this article Comparison of Approaches to Determining N-Nitrosodimethylamine Impurity in Valsartan Drug Substance By GC-MS Methods
- Authors: Khorol’skii M.D.1,2, Anan’ina O.V.2, Chaplenko A.A.2, Nedkov I.V.2, Maslennikova N.V.2, Ramenskaya G.V.1
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Affiliations:
- I. M. Sechenov First Moscow State Medical University (Sechenov University)
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- Issue: Vol 53, No 8 (2019)
- Pages: 766-770
- Section: Article
- URL: https://ogarev-online.ru/0091-150X/article/view/245987
- DOI: https://doi.org/10.1007/s11094-019-02076-y
- ID: 245987
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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.
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About the authors
M. D. Khorol’skii
I. M. Sechenov First Moscow State Medical University (Sechenov University); Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Author for correspondence.
Email: mkhorolski@gmail.com
Russian Federation, 8/2 Trubetskaya St, Moscow, 119991; 8/2 Petrovskii Blvd, Moscow, 127051
O. V. Anan’ina
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: mkhorolski@gmail.com
Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051
A. A. Chaplenko
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: mkhorolski@gmail.com
Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051
I. V. Nedkov
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: mkhorolski@gmail.com
Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051
N. V. Maslennikova
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: mkhorolski@gmail.com
Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051
G. V. Ramenskaya
I. M. Sechenov First Moscow State Medical University (Sechenov University)
Email: mkhorolski@gmail.com
Russian Federation, 8/2 Trubetskaya St, Moscow, 119991
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