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ICP versus AA: How to determine appropriate specification for assay method verification

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ChemistAnalytical

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#1
#1
Hi all,

My question is how do we come up with an appropriate specification for verification of an assay method. One method is AA. The one to be verified is ICP. I'm searching USP/ICH. An approach is not clear to me.

Is there already a guidance that addresses this?

Best regards,
 
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#2
#2
ChemistAnalytical said:
Hi all,
My question is how do we come up with an appropriate specification for verification of an assay method. One method is AA. The one to be verified is ICP. I'm searching USP/ICH. An approach is not clear to me.
Is there already a guidance that addresses this?
Best regards,
Click to expand...
I haven't found one yet., although there' are quite a few references.,
USP <730> PLASMA SPECTROCHEMISTRY
outlines accuracy, precision, intermediate precision, LOQ, linearity and robustness with respective acceptance criteria

another US FDA ref...
Elemental Analysis Manual (EAM) for Food and Related Products


Validating ICP-MS for the Analysis of Elemental Impurities According to Draft USP General Chapters <232> and <233>


Performance characteristics for the quantification of total iron in premixtures and feedingstuffs :- an ref. from EMA pg.7
1547517846410.png
Electronic Supplementary Material (ESI) for Journal of Analytical Atomic Spectrometry. This journal is © The Royal Society of Chemistry 2015
Analytical method Validation: ICP-OES

Comparison of 4 analytical techniques based on atomic spectrometry for the determination of total tin in canned foodstuffs
1547517968053.png
Validation of an analytical method based on the high-resolution continuum source flame atomic absorption spectrometry for the ...

and if you are purist, then we can adopt one of the general chapters from USP 1210 and 1010 for determining the specification of assay-verification criteria.
 

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