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

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Pharmaceutical Chemistry Journal Aims and scope

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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Authors and Affiliations

  1. I. M. Sechenov First Moscow State Medical University (Sechenov University), 8/2 Trubetskaya St, Moscow, 119991, Russia

    M. D. Khorol’skii & G. V. Ramenskaya

  2. Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051, Russia

    M. D. Khorol’skii, O. V. Anan’ina, A. A. Chaplenko, I. V. Nedkov & N. V. Maslennikova

Authors
  1. M. D. Khorol’skii
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  2. O. V. Anan’ina
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  3. A. A. Chaplenko
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  4. I. V. Nedkov
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  5. N. V. Maslennikova
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  6. G. V. Ramenskaya
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Corresponding author

Correspondence to M. D. Khorol’skii.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 53, No. 8, pp. 53 – 58, August, 2019.

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Khorol’skii, M.D., Anan’ina, O.V., Chaplenko, A.A. et al. Comparison of Approaches to Determining N-Nitrosodimethylamine Impurity in Valsartan Drug Substance By GC-MS Methods. Pharm Chem J 53, 766–770 (2019). https://doi.org/10.1007/s11094-019-02076-y

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  • DOI: https://doi.org/10.1007/s11094-019-02076-y

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