Analysis of information sources in references of the Wikipedia article "雷尼替丁" in Chinese language version.
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|PMC=缺少标题 (帮助). 2013, 8 (3). Bibcode:2013PLoSO...856498T. PMC 3587620 |article-number= (帮助)|PMC=缺少标题 (帮助). 2013, 8 (3). Bibcode:2013PLoSO...856498T. PMC 3587620 |article-number= (帮助)|PMC=缺少标题 (帮助). February 2011, 43 (1): 76–77. PMC 3062128 |PMC=缺少标题 (帮助). September 2022, 19 (19). PMC 9566239 |article-number= (帮助)FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. The FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA.
FDA recommends using an LC-HRMS testing protocol to test samples of ranitidine. FDA's LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples.
All oral formulations of ranitidine are shortly anticipated to be out of stock until further notice. This alert provides healthcare professionals with advice on the management of patients currently taking ranitidine.
|PMC=缺少标题 (帮助). 2013, 8 (3). Bibcode:2013PLoSO...856498T. PMC 3587620 |article-number= (帮助)|PMC=缺少标题 (帮助). February 2011, 43 (1): 76–77. PMC 3062128 |PMC=缺少标题 (帮助). September 2022, 19 (19). PMC 9566239 |article-number= (帮助)ranitidine formed millions of nanograms of NDMA [per tablet]
Valisure discovered the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication, and first notified the FDA of its initial findings in June of 2019
FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. The FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA.
FDA recommends using an LC-HRMS testing protocol to test samples of ranitidine. FDA's LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples.
Valisure discovered the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication, and first notified the FDA of its initial findings in June of 2019
ranitidine formed millions of nanograms of NDMA [per tablet]
All oral formulations of ranitidine are shortly anticipated to be out of stock until further notice. This alert provides healthcare professionals with advice on the management of patients currently taking ranitidine.