Asahi Kasei now offers Ceolus™ microcrystalline cellulose (MCC) with nitrite levels of 0.1 μg/g (ppm) or less.
According to the other article, some competitors assure nitrite levels of 0.2 ppm in MCC. The MCC will help reduce the risk of nitrosamine contamination.
Thanks, Yosuke; the question that always emerges is: Does everybody need sub-ppm nitrite excipients in their formulations? … The answer: depends on your formulation! It should not be a blanket requirement for everything to be sub ppm level!
Hi @Naiffer_Host ,
I agree with you. Excipients with nitrite of sub-ppm level are one of the options. We have several options such as changing the formulation, adding an anti-oxidant or pH modulator, and expanding AI by additional in-vitro and in-vivo tests.
Anyway, excipients with low nitrite levels help reduce the amount of nitrosamines in some cases. We appreciate the efforts by excipients manufacturers.
Dear both,
minimizing the nitrite levels in the excipients is the ‘‘easiest’’ way to face any issue with nitrosamines in your product. Changes of the formulation are connected with regulatory issues which in some cases are in a ‘‘grey’’ zone and the appropriate strategy in not always clear.
This level of nitrites is very impressive and most probably will help a lot in cases of Metformin and Sitagliptin.
Totally agree that having less nitrite in the excipients is a move in the right direction
