Validating a Method
If you need to demonstrate that the Halogen Moisture Analyzer produces the
same results as the reference method, the following information will be of use
to you. One possible procedure is presented using the example of ethyl cellulose.
Depending on the industry in question, the validation requirements may differ.
First Step: Method Development
You perform a method development and
determine the parameters with which you can measure the correct
moisture content of your sample. In other words, you obtain both
correct and precise results when compared to the reference
method (in this case: drying oven).
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The Halogen Moisture Analyzers offer
both precision and speed. You save time and costs and increase
efficiency.
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Second Step: Check the Linearity
Now check the linearity for a particular range.
Here, you want to demonstrate that the Halogen Moisture Analyzer
produces the same values as the reference procedure even if the
substance has a different moisture content to the one used for method
development.
To do this, condition, for example, two further moisture contents for
your sample. In this example dry the ethyl cellulose to 0.4% moisture
content and moisten it to 2.6% moisture content.
Now measure the moisture content of the two conditioned samples both
with the reference method and the method developed for the Halogen
Moisture Analyzer. Calculate the mean values and standard deviations of
the results of both procedures and evaluate whether the results are
within your defined tolerances. You can draw a diagram like the one
below.
The validation graph shows that the results
of the moisture measurement recorded with the HR83 match those values
obtained using an oven. However, the results are obtained up to 10
times faster.
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