Dear Nitrosamines Experts!!!,
Hope everything is controlled and within the limits
Iām wondering about the possibility of formation of N-nitroso Nitazoxanide due to formula as the manufacturing process includes acidic pH range (3.0-6.5) favored by citric acid as buffering agent.
The CPCA decision tree; attached;
The structure of N-nitroso nitazoxanide has no alpha hydrogens on its alpha carbons; so its potency will be controlled according to category 5 with AI= 1500 ng/day.
I need your support and experience to make sure about its possibility of formation and the limit of controlling it.
My regards,
CPCA scoring for N -nitroso cpds.pdf (224.7 KB)
![N-nitroso Nitazoxanide](https://nitrosamines.usp.org/uploads/db7259/original/2X/3/35a8adb19b54f267307d2bf5283e8e77fb1de032.png)