Chromatography Forum

Dear all,

I plan to perform a residual solvent method validation in the next couple of weeks, the problem is that offical referece standards are not readily available.

So I want to character some high purity solvents from commercial source as working standards.

Is this acceptable from a regulatory perspective?

If the answer is, then how to conduct the charcterization?

Thanks in advance.

Terry

I think you should record the lot numbers of the solvents you wish to characterize.

Get certificates of analysis from the manufacturers for those solvent lots.

Perform your own checks of purity by chromatography and other means if possible.

Maintain good records and recheck purity periodically once the bottles are opened unless you only use a bottle only once. (purchase many small bottles)

This has been my experience for good lab practise.

best wishes,

Rod

Thanks a lot, Rod.

Terry