Chromatography Forum

Hi,

I'm working on USP Method verification's. My Question is regarding RI Detectors and their Temperature maintenance. there is no RI Detector Temperature criteria for Sucralose, NF Assay method (USP37-NF32). when we were doing the method verification for this method, we kept the detector temperature ambient. But, the detector was not at all stabilizing. so we opted to 35°C and we got good results with repeat-ability and reproducibility. But in <621> system Suitability there is no criteria for RI Detector Temperature variation. So we contacted USP and their answer was to validate this method. Do i need to validate this method or verification is good?

Hello

RI detector is very temperature sensitive. I would reccomend at least 5 deg above ambient temperature but very common temperature for optical unit is 40 deg. It works for most of analytical methods.

Regards

Tomasz Kubowicz

So we contacted USP and their answer was to validate this method. Do i need to validate this method or verification is good?

This is a USP method. You asked them what to do. They answered.
What part of "validate this method" is unclear?