RI Detector Temperature

[madhavi]

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?

[kubowicz.tomasz]

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

[tom jupille]

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?