<i>N</i>-Nitrosodimethylamine Contamination in the Metformin Finished Products
A GC–MS/MS method with EI ionization was developed and validated to detect and quantify <i>N</i>-nitrosodimethylamine (NDMA) and seven other nitrosamines in 105 samples of metformin tablets from 13 different manufactures. Good linearity for each compound was demonstrated over the calibra...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-11-01
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| Series: | Molecules |
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| Online Access: | https://www.mdpi.com/1420-3049/25/22/5304 |
| _version_ | 1797547995153039360 |
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| author | Adam Zmysłowski Iza Książek Arkadiusz Szterk |
| author_facet | Adam Zmysłowski Iza Książek Arkadiusz Szterk |
| author_sort | Adam Zmysłowski |
| collection | DOAJ |
| description | A GC–MS/MS method with EI ionization was developed and validated to detect and quantify <i>N</i>-nitrosodimethylamine (NDMA) and seven other nitrosamines in 105 samples of metformin tablets from 13 different manufactures. Good linearity for each compound was demonstrated over the calibration range of 0.5–9.5 ng/mL. The assay for all substances was accurate and precise. NDMA was not detected in the acquired active pharmaceutical ingredient (API); however, NDMA was detected in 64 (85.3%) and 22 (91.7%) of the finished product and prolonged finished product samples, respectively. European Medicines Agency recommends the maximum allowed limit of 0.032 ppm in the metformin products. Hence, 28 finished products and 7 pronged dosage products were found to exceed the acceptable limit of daily intake of NDMA contamination. The implications of our findings for the testing of pharmaceutical products are discussed. |
| first_indexed | 2024-03-10T14:52:02Z |
| format | Article |
| id | doaj.art-9e64aaccb79f4773a5cb4391ede0ce23 |
| institution | Directory Open Access Journal |
| issn | 1420-3049 |
| language | English |
| last_indexed | 2024-03-10T14:52:02Z |
| publishDate | 2020-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Molecules |
| spelling | doaj.art-9e64aaccb79f4773a5cb4391ede0ce232023-11-20T20:54:24ZengMDPI AGMolecules1420-30492020-11-012522530410.3390/molecules25225304<i>N</i>-Nitrosodimethylamine Contamination in the Metformin Finished ProductsAdam Zmysłowski0Iza Książek1Arkadiusz Szterk2National Medicines Institute, 30/34 Chełmska, 00-725 Warsaw, PolandNational Medicines Institute, 30/34 Chełmska, 00-725 Warsaw, PolandNational Medicines Institute, 30/34 Chełmska, 00-725 Warsaw, PolandA GC–MS/MS method with EI ionization was developed and validated to detect and quantify <i>N</i>-nitrosodimethylamine (NDMA) and seven other nitrosamines in 105 samples of metformin tablets from 13 different manufactures. Good linearity for each compound was demonstrated over the calibration range of 0.5–9.5 ng/mL. The assay for all substances was accurate and precise. NDMA was not detected in the acquired active pharmaceutical ingredient (API); however, NDMA was detected in 64 (85.3%) and 22 (91.7%) of the finished product and prolonged finished product samples, respectively. European Medicines Agency recommends the maximum allowed limit of 0.032 ppm in the metformin products. Hence, 28 finished products and 7 pronged dosage products were found to exceed the acceptable limit of daily intake of NDMA contamination. The implications of our findings for the testing of pharmaceutical products are discussed.https://www.mdpi.com/1420-3049/25/22/5304NDMAnitrosaminesGC-MSmetformin |
| spellingShingle | Adam Zmysłowski Iza Książek Arkadiusz Szterk <i>N</i>-Nitrosodimethylamine Contamination in the Metformin Finished Products Molecules NDMA nitrosamines GC-MS metformin |
| title | <i>N</i>-Nitrosodimethylamine Contamination in the Metformin Finished Products |
| title_full | <i>N</i>-Nitrosodimethylamine Contamination in the Metformin Finished Products |
| title_fullStr | <i>N</i>-Nitrosodimethylamine Contamination in the Metformin Finished Products |
| title_full_unstemmed | <i>N</i>-Nitrosodimethylamine Contamination in the Metformin Finished Products |
| title_short | <i>N</i>-Nitrosodimethylamine Contamination in the Metformin Finished Products |
| title_sort | i n i nitrosodimethylamine contamination in the metformin finished products |
| topic | NDMA nitrosamines GC-MS metformin |
| url | https://www.mdpi.com/1420-3049/25/22/5304 |
| work_keys_str_mv | AT adamzmysłowski ininitrosodimethylaminecontaminationinthemetforminfinishedproducts AT izaksiazek ininitrosodimethylaminecontaminationinthemetforminfinishedproducts AT arkadiuszszterk ininitrosodimethylaminecontaminationinthemetforminfinishedproducts |