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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...

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Detalles Bibliográficos
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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2019
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