Water Content (KF) Method Validation

[tubish81]

Hi,
How can I perform method validation of water content with KF? Is there any acceptance critieria for the validation parameters?

Thank you

[mattmullaney]

Hi Tubish81,

You could consult Mettler-Toledo's white paper "Validation of Titration Methods - A Guideline for Customers", I think it is Applications Brochure 16. It could be that Metrohm has a similar white paper.

[tubish81]

Thank you MattM:)
I’ll investigate this document.

[HPLC chemist]

The USP also has a separate section on KF titrations and methodology. I can't remember the section number.

[dap]

European Pharmacopoeia 2.5.12 Suitability.

[mattmullaney]

Hi Tubish81,

Were you able to find and read the Mettler whitepaper, "Validation of Titration Methods - A Guideline for Customers", Applications Brochure 16?

[tubish81]

Hi Matt,
Thank you so much. I found Mettler whitepaper. I'll write SOP by using the document.

[kalylcie]

Calculate the relative standard deviation (RSD) for both repeatability (intra-day) and intermediate precision (inter-day). Acceptable RSD values depend on your specific application but are typically <2% for both. among us

[Lawrence3]

That's a great question! When validating a Karl Fischer (KF) method for water content determination, you'll typically need to assess parameters like accuracy (using a certified reference material), precision (repeatability and intermediate precision), linearity (over the expected range of water content), and robustness (impact of small changes in parameters). Acceptance criteria depend on the specific application and industry guidelines, but generally, you'd want accuracy within a defined percentage of the reference material value, and good precision with a low RSD. Reminds me of the need for precise control in games like Drift Hunters, where even small errors can lead to big crashes! Look for guidelines from USP, EP, or AOAC for more specific guidance.