Hi,

Is there any official document to know how to fix a Peak Purity criteria to confirm the peak purity in a HPLC Assay ?

We work with an Agilent 1100 DAD, and we could do a Peak Purity....

Thanks

Any related document would be appreciated

KAF

Hi KAF,

What do you mean by "official", from agilent, or from the FDA, EPA, etc.?

I believe with ChemStation and the 1100 DAD you can have the software automatically calculate a threshold value base on signal to noise or you can manually set a threshold value. Back when we used ChemStation I had the software automatically calculate the threshold value.

Thanks Tom !!!

When I said "official" method I was thinking on something that would be accepted by the FDA or any other Health Authority when you develop a method and want to prove that the method is Stability Indicating and Suitable for Stability studies...

Related with Chemstation Software, sometimes I had problems with the thereshold value if it's automatically calculated by the system. A peak witha Puritu Factor 99.985 it could be considered as a not pure peak.

Any related document ? (USP doesn't specify the specific system to evaluate a peak purity).

Would be accepted a MS detector ??

Thanks

In a word: NO.

Sorry Anonymous !!!!

No, what ??

I need more details

Thanks