Qualitative & Quantitative Analysis of Nitrosamines by FTIR

An interesting paper that looks to be worthy of further investigation.

Whether it would work in a drug product matrix?

Does it work for NDSRIs?

Can it be made sensitive enough to remove the need for mass-spec testing on QC release?

View of Simultaneous assessment of nitrosamines NDBA, NDEA, NDMA, and NDIPA: quantitative and qualitative analysis using FTMIR KBr pellets and ATR-FTMIR spectroscopy

1 Like

My turn off is the LOD/LOQ reached… my hopes continues on qNMR as their quantitative capacity continues to evolve and goes lower and lower!

Oh I agree @Naiffer_Host - my hope is that limits for NSDRIs rise with time as more tox data and approaches become available/accepted by authorities, and so the LOQ values are no longer the limiting factors :smiley:

I cannot imagine the whole process, like mixing KBr with NDMA, forming a pellet/disk, placing NAs on ATR crystal, without thinking about contamination hazards.

2 Likes

It would definitely be great, but my question would be how feasible would it to be implemented in the industrial landscape? I truly do not believe that many manufacturing sites have NMR on site, and I am not sure how many times the business need will justify the investment…

Having said that, as an organic chemist myself I am quite interested, is there any good literature showing the progress being made in determination of nitrosamines by qNMR? In general the technique would bring great value for the structural determination of impurities in general

2 Likes

Point taken Javier, but do not forget the benchtop NMR and digital standards! technology is moving very fast, even USP has not included the use of digital standards for those scenarios… the future is not galaxies far away!

2 Likes

I’ve been keeping an eye on the benchtop NMR progress - don’t feel that it is there for “normal” degs yet - not enough to be able to justify the expense of implementation in R&D labs and then all associated QC labs, but it is certainly coming on leaps and bounds.

One for future discussion in the new USP Exchange?

1 Like