Chromatography Forum

I am a chromatography (for many many years now) but now I want to buy an FTIR to supplement my HPLC lab. What I want to do is prepare a library of bulk drugs and excipients used for one particular product. Then, I would like to evaluate other products to determine if they are authentic or generic. Anyone doing this type of work? Any suggestions as to the type of equipment that would be most suitable to these types of evaluations. This is real money (my money) so I want to be sure I spend it wisely.

If you're after matches of scans for a very specific item (Tylenol 500mg tablets, for example), all you need to do is build a library from scans of several lots of material and you can use that to tell counterfeit from authentic tablets (or ground tablet samples).

If you're interested in being able to discern a particular sample from any 500mg acetaminoophen tablet, you will have to do a lot more work (lots of principle component analysis - the original PCA), and in the case of very low dose drugs, you may not even be able to discern a placebo from a tablet containing the active ingredient.

As to specifics, I'd be inclined to talk to Thermo before I'd talk to Brimrose. Those are the only two with whom I've had any experience - and that was third hand.

If you're in a regulated lab environment, (Thermo) Nicolet instruments can be purchased with a user qualification binder which speeds up any software validation you may need to perform.

Thermo Nicolet FTIR also has "QC Compare" software which can automatically compare your sample v. a library you make of known good product, to provide a YES/NO comparison. You set the limits on how close is close enough; you run a few standards to build the library database. And the ATR diamond cells are worth every penny !