🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2

Yes, several examples of small nitrosamines where CPCA is now adopted like seen in other territories (NMPA, NMBA, NDIPA, NEIPA).
Also some smaller ones which had temporary limits published on separate webpages which are now integrated based on CPCA (1-methyl-4-nitrosopiperazine, 1-cyclopentyl-4-nitrosopiperazine).
But most remarkable evolution on the small nitrosamine front is N-nitrosopiperazine to N-nitrosopiperidine readacross (1300 ng/day). We haven’t seen that published elsewhere and I’m wondering if it starts to open a door for the re-evaluation of 400 ng/day as class value for category 3.

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