Low Nitrite Excipients - it’s happening

We are starting to see excipients supplier going above and beyond to be part of the solution when it comes mitigating levels of nitrite in excipients.

How has been your experience with your excipient suppliers?!

A good example


That is great news. I am glad to see this progression.

There are several excipients that recently have been offered low nitrite content from several suppliers by means of historical data or actual analysis in the specification (MCC, Lactose, Starch) since some time already. Recently, DuPont as seen in your post.

Personally, I think that is very good, b/c the excipients I mentioned (+ others) are used in quite a lot of formulas and recently it was shown in a webinar how dealbreaking this could be in a reformulation/source change. Nevertheless, I could say there are some excipients where this Low nitrite version is not expected by manufacturers. But well is complicated, at the end pharma is not neccesary the biggest client.

This goes in conjuction with the limits, if we get rid of the 18 ng/day, it would not be neccesary to change all sources for a low nitrite source (that is not realistic anyways) :slight_smile: