Editor’s note: This article was updated on 5 September to correct information related to daily acceptable intake (AI) limits for nitrosamines and on 6 September to add a reference to FDA's webpage for ...
An immediately effective guidance from the US Food and Drug Administration (FDA) details steps to be taken to detect and prevent the introduction of potentially carcinogenic nitrosamine impurities ...
Nitrosamines arise via nitrosating agents (nitrites, NO2/NOx, nitrous acids/oxides) reacting with secondary/tertiary amines or some amides, yielding high-risk N-nitroso compounds. Regulatory actions ...
A groundbreaking three-year collaborative pilot project between USP and Vietnam's National Institute for Drug Quality Control (NIDQC) has been successfully completed and is recently receiving ...
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