Open AccessIn Vitro Analysis ofN-Nitrosodimethylamine (NDMA) Formation From Ranitidine Under Simulated Gastrointestinal Conditions
Author(s) -
Zongming Gao,
Michael Karfunkle,
Wei Ye,
Tim Andres Marzan,
Jingyue Yang,
Timothy R. Lex,
Cynthia D. Sommers,
Jason D. Rodriguez,
Xiaomei Han,
Jeffry Florian,
David G. Strauss,
David A. Keire
Publication year - 2021
Publication title -
jama network open
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.278
H-Index - 39
ISSN - 2574-3805
DOI - 10.1001/jamanetworkopen.2021.18253
Subject(s) - ranitidine , nitrite , chemistry , n nitrosodimethylamine , gastric fluid , chromatography , nitrosamine , carcinogen , biochemistry , medicine , organic chemistry , nitrate
Key Points Question Does ranitidine convert to N -nitrosodimethylamine (NDMA), a probable human carcinogen, in simulated gastric fluid at physiologic pH levels and nitrite concentrations? Findings In this in vitro study of 150-mg ranitidine tablets added to simulated gastric fluid, NDMA did not form when gastric nitrite concentrations were at the upper range of physiologic or at nitrite concentrations as much as 50-fold greater than the upper range. Meaning In this study, 150-mg ranitidine tablets did not convert to NDMA in simulated gastric fluid with physiologic nitrite concentrations.
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