Chromatography Forum

We are validating a residual solvent method. It is a GC-HS method.

I would like to know that solution stabilty has to be performed for residual solvents analysis or not ?

As per my opinion it should not be performed, but this method we are validating for other party, they have mentioned in their protocol.

Regards

AKJ

There are two simple answers; 1. if solution stability can affect the result, then solution stability has to be included in the validation, 2. If the customer wants it, the customer gets it, and pays for it.

Peter

You will find that the solutions when sealed overnight, more than 3-4 hours, can give results that have higher RSDs than desired, especially for aromatics and chlorinated solvent analysis, which depends highly upon the type of seal and cap used.

I agree with Peter. What the customer wants and pays for, he gets.
Depending upon your choice of hardware, he may NEED this info as well.

best wishes,

Rod