Autotitraion validation
Posted: Fri Sep 06, 2013 5:13 pm
by Luci
Hi,
Does anyone have perform validation to determinatio for Isocyanate contern (prepolymer) by titration? If yes how you do for accuracy and linearity? Thank you in advance.
Luci
Re: Autotitration validation
Posted: Fri Sep 20, 2013 12:09 am
by KM-USA
Accuracy for a titration would be (as for HPLC) to spike and assay placebo samples, or to do as standard additions. Precision would be to assay the same sample multiple times. Linearity for many titration assays should be able to be assumed, but you could make varying concentrations and calculate the amount of titrant required.
For example, antiperspirant products are typically assayed for active by titrating the chloride content. And we have documented and validated the procedure with these discussed parameters here. Our QA says that the USP procedure is only for USP raw materials, so must be validated to use on finished products.
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