We are equivalence in-house method with USP method. For this, we are looking to fix acceptance criteria for The absolute mean difference between both the methods. Please suggest the acceptance criteria for the HPLC Equivalency Assay Test with Reference.
Acceptance criteria for the HPLC Equivalency Assay Test with Reference is 98.0% to 102% with 2% RSD.
It depends on your label claim. For a supplement that uses a natural substance as a raw material it could be 95.0% to 105.0% (note the 0, since it is based on the USP general chapter on numbering) or a pharmaceutical API raw material of 99.0% to 101.0%, thus the finished product would be 98.0% to 102.0% (this will depend on your clinical studies!)
For an equivalency report the acceptance criteria MUST be the same or BETTER than obtained in the USP HPLC method. OR you can demonstrate that the USP method is not appropriate for your sample matrix (for example a placebo peak, impurity interferes with the quantitation).
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