Determination of Nitrosamines in Various Pharmaceuticals at Variable Temperatures

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dc.contributor.authorCanbolat, Fadime
dc.contributor.authorAydın, Ahmet
dc.date.accessioned2025-05-29T05:21:21Z
dc.date.available2025-05-29T05:21:21Z
dc.date.issued2024
dc.departmentÇanakkale Onsekiz Mart Üniversitesi
dc.description.abstractNitrosamines have been classified as potent genotoxic agents for humans by the International Agency for Research on Cancer. Our study aimed to determine the levels of nitrosamine impurities that could be formed in the content of drugs under different temperature conditions during their shelf life using chromatographic analysis. Eleven drugs in pharmacies were subjected to long-term exposure at two different temperatures. Twelve nitrosamine impurities of all samples were performed using LC-MS/MS. When the impurity levels of the analyzed drugs were examined, no nitrosamine impurity was detected in any drugs. Our study revealed that if no impurity was detected under storage conditions, there was no impurity formation even when the temperature was increased. When impurity formation is effectively prevented during the manufacturing stage, the risk of impurity occurrence during the shelf-life of drugs belonging to the same group is estimated to be low
dc.description.abstractNitrosamines have been classified as potent genotoxic agents for humans by the International Agency for Research on Cancer. Our study aimed to determine the levels of nitrosamine impurities that could be formed in the content of drugs under different temperature conditions during their shelf life using chromatographic analysis. Eleven drugs in pharmacies were subjected to long-term exposure at two different temperatures. Twelve nitrosamine impurities of all samples were performed using LC-MS/MS. When the impurity levels of the analyzed drugs were examined, no nitrosamine impurity was detected in any drugs. Our study revealed that if no impurity was detected under storage conditions, there was no impurity formation even when the temperature was increased. When impurity formation is effectively prevented during the manufacturing stage, the risk of impurity occurrence during the shelf-life of drugs belonging to the same group is estimated to be low.
dc.identifier.doi10.19127/bshealthscience.1377252
dc.identifier.endpage66
dc.identifier.issn2619-9041
dc.identifier.issue2
dc.identifier.startpage55
dc.identifier.urihttps://doi.org/10.19127/bshealthscience.1377252
dc.identifier.urihttps://hdl.handle.net/20.500.12428/30592
dc.identifier.volume7
dc.language.isoen
dc.publisherCem TIRINK
dc.relation.ispartofBlack Sea Journal of Health Science
dc.relation.publicationcategoryMakale - Ulusal Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.snmzKA_DergiPark_20250529
dc.subjectDrug
dc.subjectImpurity
dc.subjectLC-MS/MS
dc.subjectNitrosamine
dc.subjectToxicology
dc.titleDetermination of Nitrosamines in Various Pharmaceuticals at Variable Temperatures
dc.typeResearch Article

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