Determination of genotoxic impurities in pharmaceutical substances
- Authors: Ananyina O.V.1, Khorolsky M.D.1,2, Ramenskaya G.V.1, Zhukov E.A.1, Maslennikova N.V.1
-
Affiliations:
- Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
- Issue: Vol 69, No 7 (2020)
- Pages: 10-16
- Section: Articles
- URL: https://journals.eco-vector.com/0367-3014/article/view/113396
- DOI: https://doi.org/10.29296/25419218-2020-07-02
- ID: 113396
Cite item
Abstract
Keywords
Full Text
About the authors
Olga Vyacheslavovna Ananyina
Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation
Email: olga_ananina96@mail.ru
Senior Laboratory Assistant of the Pharmacopoeial Analysis Laboratory
Mikhail Dmitrievich Khorolsky
Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Email: mkhorolski@gmail.com
Senior Laboratory Assistant of the Biomedical Cellular Products Laboratory
Galina Vladislavovna Ramenskaya
Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation
Email: ramenskaia@mail.ru
Director of the Institute of Pharmacy named after А.P.Nelyubin of Sechenov University, Head of the Department of the pharmaceutical and toxicological chemistry named after A.P. Arzamastsev of Sechenov University, Doctor of Pharmaceutical Sciences, Professor.
Evgeniy Andreevich Zhukov
Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation
Email: zhukovea@expmed.ru
1-st category expert of Pharmacopoeia Analysis Laboratory
Natalia Viktorovna Maslennikova
Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation
Email: tixux@mail.ru
Head of the Laboratory of pharmacopeia analysis
References
- Биглова Ю.Р., Гадасина Н.В., Боковикова Т.Н. и др. Неспецифические примеси в фармацевтических субстанциях: особенности методик их определения. Ведомости Научного центра экспертизы средств медицинского применения. 2019; 9 (3): 153-61. doi: 10.30895/1991-2919-2019-9-3-153-161 [Biglova Y.R., Gadasina N.V., Bokovikova T.N. et al. Nonspecific Impurities in Pharmaceutical Substances: Characteristics of Test Methods. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2019; 9 (3): 153-61. doi: 10.30895/1991-2919-2019-9-3-153-161 (in Russian) ]
- M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk. [Electronic resource]. Access mode: https:// www.fda.gov/media/85885/download
- International council for harmonisation of technical requirements for pharmaceuticals for human use (ICH). Assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk M7(R1).
- ICH, Q1A (R2) Stability Testing of New Drug Substances and Products (Nov. 2003).
- Munster-Muller, S., Hansen, S., Opatz, T. et al. Chemical profiling of the synthetic cannabinoid MDMB-CHMICA: identification, assessment and stability study of synthesis-related impurities in seized and synthesized samples. Drug Testing and Analysis. 2019. doi: 10.1002/dta.2652
- International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH). Impurities in new drug products q3b(r2). [Electronic resource]. Access mode: https://database.ich.org/sites/default/ files/Q3B_R2__Guideline.pdf
- Thybaud V., Aardema M., Clements J. et al. Strategy for genotoxicity testing: Hazard identification and risk assessment in relation to in vitro testing. Mutation Research/Genetic Toxicology and Environmental Mutagenesis, 2007; 627 (1): 41-58.
- FDA, Drug recall. [Electronic resource]. Access mode: https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls
- Фармацевтический вестник. [Электронное издание]. Режим доступа: https://pharmvestnik.ru/content/news/hetero-drugs-otzyvaet-preparaty.html [Farmatsevticheskiy vestnik. [Electronic resource]. Access mode: https://pharmvestnik.ru/con-tent/news/hetero-drugs-otzyvaet-preparaty.html (in Russian)]
- European Medicines Agency Evaluation of Medicines for Human Use (EMA). Guideline on the limits of genotoxic impurities.
- Gooty A. R., Katreddi H. R., Hunnur, R.K. et al. Simultaneous Determination of Genotoxic Impurities in Fudosteine Drugs by GC-MS. Journal of Chromatographic Science. 2016; 54 (8): 1277-81. doi: 10.1093/chromsci/bmw070
- Ho T.D., Yehl P.M., Chetwyn N.P. et al. Determination of trace level genotoxic impurities in small molecule drug substances using conventional headspace gas chromatography with contemporary ionic liquid diluents and electron capture detection. Journal of Chromatography A. 2014; 1361: 217-28. doi:10.1016/j. chroma.2014.07.099
- Harigaya K., Yamada H., Yaku K. et al. (2014). Development and Validation of a Sensitive GC-MS Method for the Determination of Alkylating Agent, 4-Chloro-1-butanol, in Active Pharmaceutical Ingredients. Chemical and Pharmaceutical Bulletin. 2014; 62 (4): 395-8. doi: 10.1248/cpb.c13-00916
- Reddy S.R., Reddy K.H., Kumar M.N. et al. A Validated GC-MS Method for the Determination of Genotoxic Impurities in Divalproex Sodium Drug Substance. J. of Chromatographic Science. 2018. doi: 10.1093/chromsci/bmy089
- Wu C.-H., Xu F., Chang X.-L. et al. Determination of 1-bromopropane in workplace air by GC-FID. Zhonghua Laodong Weisheng Zhiyebing Zazhi. 2013; 31: 467-9.
- Li Z., Wang H., Wang H., Ren X. Method for detection of n-propyl bromide in leather and textile by GC-MS. Faming Zhuanli Shenqing. 2014. CN103604899A Feb 26.
- Genotoxic and carcinogenic impurities in drug substances and products: recommended approaches. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Silver Spring, MD. USA, 2008.
- Guideline on the Limits of Genotoxic Impurities, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMEA), London, 2006 (CPMP/ SWP/5199/02, EMEA/CHMP/QWP/251344/2006)
- Zhang C., Huang L., Wu Z., et al. Determination of sulfonate ester genotoxic impurities in imatinib mesylate by gas chromatography with mass spectrometry. J. of Separation Science. 2016; 39 (18): 3558-63. doi: 10.1002/jssc.201600389
- Liu Z., Fan H., Zhou Y., et al. Development and validation of a sensitive method for alkyl sulfonate genotoxic impurities determination in drug substances using gas chromatography coupled to triple quadrupole mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis. 2018. DOI:10.1016/j. jpba.2018.12.044
- Council of Europe. Enquiry: alkyl mesilate (methanesul-phonate) impurities in mesilate salts. Pharmeuropa. 2000; 12: 27.
- Khan M., Jayasree K., Reddy K.V.S.R. K. & Dubey P. K. A validated CE method for determining dimethylsulfate a carcinogen and chloroacetyl chloride a potential genotoxin at trace levels in drug substances. Journal of Pharmaceutical and Biomedical Analysis. 2012; 58: 27-33. DOI:10.1016/j. jpba.2011.09.019
- USP 42-NF 37 (467) RESIDUALSOLVENTS. [Electronic resource]. Access mode: https://www.uspnf.com/
- European Pharmacopoeia (Ph. Eur.) 9th Edition. 2.4.24. Identification and control of residual solvents. [Electronic resource]. Access mode: https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-9th-edition
- Государственная фармакопея Российской Федерации XIV издание. ОФС.1.1.0008.15. «Остаточные органические растворители.» [Электронное издание]. Режим доступа: https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-9th-edition [The State Pharmacopoeia оf the Russian Federation, XIV-ed. OFS.1.1.0008.15. "Residual organic solvents." [Electronic resource]. Access mode: https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-9th-edition (in Russian) ]
- International council for harmonisation of technical requirements for pharmaceuticals for human use (ICH). Impurities: guideline for residual solvents Q3C(R6). [Electronic resource]. Access mode: https://www.ema.europa.eu/en/docu-ments/scientific-guideline/international-conference-harmonisa-tion-technical-requirements-registration-pharmaceuticals-hu-man-use_en-33.pdf
- Nowak T., Graffius G.C., Liu Y. et al. GC-FID method for high-throughput analysis of residual solvents in pharmaceutical drugs and intermediates. Green Chemistry. 2016; 18 (13): 3732-9. doi: 10.1039/c6gc01210h
- Huang Y., Lu H., Zhang F., & Min C. Identification, isolation, characterization and ultra-performance liquid chromatography quantification of potential genotoxic impurities in linagliptin. J. of Separation Science. 2018. doi: 10.1002/jssc.201800623
- Wolff F.C., Dillenburg T.L., Venzon Antunes M. Characterization of imatinib mesylate formulations distributed in South American countries: Determination of genotoxic impurities by UHPLC-MS/MS and dissolution profile. Biomedical Chromatography. 2018; 32 (7): e4222. doi: 10.1002/bmc.4222
- Carapic M., Nikolic K., Markovic B. et al. Ultraperformance liquid chromatography tandem mass-spectrometry (UHPLC-MS/MS) for the rapid, simultaneous analysis of ziprasi-done and its impurities. Biomedical Chromatography. 2018; e4384. doi: 10.1002/bmc.4384
- Vijaya Bhaskar Reddy A., Venugopal N., Madhavi G. A selective and sensitive UPLC-MS/MS approach for trace level quantification of four potential genotoxic impurities in zolmi-triptan drug substance. Journal of Pharmaceutical and Biomedical Analysis. 2013; 84: 84-9. doi: 10.1016/j.jpba.2013.05.047
- GC/MS Headspace Method for Detection of NDMA in Valsartan Drug Substance and Drug Products. [Electronic resource]. Access mode: https://www.fda.gov/media/115965/ download
- Combined Direct Injection N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), N-Nitrosoethylisopropylamine (NEIPA), N-Nitrosodiisopropylamine (NDIPA), and N-Nitrosodibutylamine (NDBA) Impurity Assay by GC-MS/MS. [Electronic resource]. Access mode: https://www.fda.gov/media/123409/download