Peak purity vendor qualification (either LC-MS or LC-DAD)

[Rob Burgess]

On reviewing our LC-MS vendor qualification, QA asked me how do we prove peak purity testing through actual qualification testing. I told them that I wasn't aware of any vendor that would be able to do this vigorously. So the obvious question came up - how would we know the system is fit for its intended purpose?

Does anyone know if any vendor would qualify peak purity testing either for a LC-MS or a LC-DAD? I guess not, but I could be surprised

[tkubowicz]

Hello

Part of IQ/OQ for software (eg.Chemstation, MassHunter) is test called "Spectral Library/Evaluation test". This test verifies that you can create a library, add a compound to it, and then identify the compound and verify the
identification.
So if you have IQ/OQ documentation for your software, you can prove it is qualified.
I don't think you will have specific procedure for "peak purity". But above tests can prove that spectral module is working and "peak purity" is part of it.

Regards

Tomasz Kubowicz