Nitroso Dimethyl anthranilate

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Please keep this recent publication in perspective when weighting the water as a source of Nitrites…

Nitrite in Pharmaceutical Manufacturing Water: Development of an Ultra-Sensitive Analytical Method, Typical Data, and Discussion of Potential Nitrosamine Formation in Drug Substance and Drug Product from Water

Dr. Kumar et al. published a paper on nitrite in a variety of different types of water. https://pubs.acs.org/doi/10.1021/acs.oprd.4c00037 Twenty-one out of twenty-two purified water samples analyzed had nitrite levels that were below the quantitation limit of the method, i.e. <0.1 ppb. All potable water samples analyzed had nitrite levels that were <3.5 ppb. The results are contextualized to illustrate the amounts of nitrosamine that could be formed from process water during API and DP manufac…