Hello.
Do you think I can replace the identifications provided in the pharmacopoeia with NIR technique?
There are regulatory obstacles ?
Thanks
Yes (if it is science based) and no. Yes there are some frequencies that indicate a group is present (like Methyl) but there are some indications that are conclusive (like precipitation in dilute Ammonium hydroxide). I would not suggest this route unless you know what you are doing!
Each container can be identified by NIR or FTIR (with impurities or strange peaks). The indications can be performed on a combined representative sample.
Thank you. In fact I would like to identify API and excipients arriving by only stock with the NIR technique.
And exclude all other identifications required by Pharmacopeia.