I have a client requesting analysis of their DP for the presence of n-nitrososarcosine. The DP contains sarcosine as a precursor to the API, and they are concerned with the potential of forming the associated nitrosamine. I have not found a limit for this compound. Can I use the FDA NDSRI guidance and calculate an associated limit for it based on the predicted carcinogenic potency categorization?
Indeed, Nitrososarcosine carcinogenicity data is described in the literature, so you might want to compare the CPCA exercise with the available data as part of the expert review (nitrososarcosine as weak mice liver / rat esophageal carcinogen, nitrososarcosine can decompose to NDMA under certain conditions) to confirm that CPCA is protective (in case CPCA is doable).
Some references:
Wogan, G. N., Paglialunga, S., Archer, M. C., & Tannenbaum, S. R. (1975). Carcinogenicity of Nitrosation Products of Ephedrine, Sarcosine, Folic Acid, and Creatinine. Cancer Research (Chicago, Ill.) , 35 (8), 1981â1984.
Scanlan, R. A., & Issenberg, P. (1975). N-nitrosamines in foods. CRC Critical Reviews in Food Technology , 5 (4), 357â402. https://doi.org/10.1080/10408397509527180