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Rapid and efficient high-performance liquid chromatography analysis of N-nitrosodimethylamine impurity in valsartan drug substance and its products
In July 2018, certain valsartan-containing drugs were voluntary recalled in Japan owing to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen. In this study, an HPLC method was developed for the quantitative detection of NDMA simultaneously eluted with valsartan. Good line...
Autores principales: | Masada, Sayaka, Tsuji, Genichiro, Arai, Ryoko, Uchiyama, Nahoko, Demizu, Yosuke, Tsutsumi, Tomoaki, Abe, Yasuhiro, Akiyama, Hiroshi, Hakamatsuka, Takashi, Izutsu, Ken-ichi, Goda, Yukihiro, Okuda, Haruhiro |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6694186/ https://www.ncbi.nlm.nih.gov/pubmed/31413326 http://dx.doi.org/10.1038/s41598-019-48344-5 |
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