Low nitrite excipients

Root Causes Excipients
1

What do you think of making a list of excipints brands that are offered as low-nitrite grade?
for example

AVICEL® PH LN: https://www.pharmaexcipients.com/wp-content/uploads/2023/07/iff.pdf

I think we can start with fillers as are confirmed to be the largest source of nitrite in the drug products, for example:
*Microcrystalline celloluse
*Crosscarmellose sodium

2

Also DFE Pharma excipients are very low in nitrites:

DFE Nitrosamines white paper

Moreover, in our experience, also JRS MCC (Vivapur 101 and 102) have a low content of nitrites (<0.2%), even if they didn’t create a specific brand or published their data.

1 Like
3

Thanks for sharing DFE white paper.
Unfortunately, we should not rely completely on the risk assessment delivered by the suppliers on taking our decisions. When we made our analysis, we have found significant nitrite content although the risk assessment received from the excipient supplier claims its absence!