Detection of Impurities in Acetaminophen Intravenous and Oral Formulations Available on the Lebanese Market

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dc.contributor.author Rahme, Rita
dc.date.accessioned 2022-06-22T09:31:53Z
dc.date.available 2022-06-22T09:31:53Z
dc.date.copyright 2022 en_US
dc.date.issued 2022-01-27
dc.identifier.uri http://hdl.handle.net/10725/13748
dc.description.abstract Introduction: The presence of impurities in pharmaceutical formulations has been a concern worldwide. Acetaminophen is a commonly used drug for its analgesic and antipyretic properties. We report here a novel method for the impurity profiling of intravenous acetaminophen formulations by head space gas chromatography. In addition, impurity profiling of oral acetaminophen tablets and capsules available on the Lebanese market and manufactured in Lebanon was not reported, as well. Objective: The purpose of this study is to detect impurities present in intravenous and oral samples of acetaminophen on the Lebanese market and analyze the risks that these impurities pose to human health. Methods: static headspace gas chromatography- mass spectrometry was utilized as one of the most suitable methods to detect organic volatile impurities. Samples for intravenous use where first lyophilized prior to analysis. A total of 25 samples were analyzed: 9 and 16 for intravenous and oral use, respectively. Toxicological review was performed on the detected impurities and the different risks associated were analyzed. Results: of the 9 intravenous samples analyzed, 6 contained impurities. As for the oral samples, 9 out of 16 samples contained impurities. A total of 14 different impurities were detected: acetaldehyde, cyclomethicone 5, cyclomethicone 6, dibutyl phthalate, diethyl phthalate, diacetamate, ethanol, ethyl stearate, formic acid, glycidol, methyl carbamate, methyl hydrazine, methyl stearate, and triethylamine. Several of the detected impurities are highly nephrotoxic, hepatotoxic, neurotoxic, carcinogenic, and/or teratogenic. Conclusion: In view of the toxicity of the detected impurities and the negative impact they carry on the quality of the formulation as well as on human health, it is of utmost importance for the concerned pharmaceutical industries to take appropriate measures to control the source of these impurities and abide by the guidelines set by the regulatory authorities all around the world. Regulatory authorities should also take the necessary measures to preserve the safety of treated patients. en_US
dc.language.iso en en_US
dc.subject Acetaminophen -- Toxicology en_US
dc.subject Environmental chemistry en_US
dc.subject Chromatographic analysis en_US
dc.subject Lebanese American University -- Dissertations en_US
dc.subject Dissertations, Academic en_US
dc.title Detection of Impurities in Acetaminophen Intravenous and Oral Formulations Available on the Lebanese Market en_US
dc.type Thesis en_US
dc.term.submitted Fall en_US
dc.author.degree MS in Pharmaceutical Development And Management en_US
dc.author.school SOP en_US
dc.author.idnumber 201400934 en_US
dc.author.commembers Khnayzer, Rony
dc.author.commembers Mehanna, Stephanie
dc.author.department Pharmaceutical Sciences en_US
dc.description.physdesc 1 online resource (xiv, 53 leaves): ill. (some col.) en_US
dc.author.advisor Saab, Yolande
dc.keywords Impurities en_US
dc.keywords Volatile Organic Impurities en_US
dc.keywords Impurity Profiling en_US
dc.keywords Chromatography en_US
dc.keywords Headspace GC-MS en_US
dc.keywords Acetaminophen en_US
dc.keywords Toxicology en_US
dc.description.bibliographiccitations Includes bibliographical references (leaf 43-50). en_US
dc.author.email rita.rahme@lau.edu en_US
dc.identifier.tou http://libraries.lau.edu.lb/research/laur/terms-of-use/thesis.php en_US
dc.publisher.institution Lebanese American University en_US
dc.author.affiliation Lebanese American University en_US

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