2018 March 16 SPDS
Method Performance Requirements: Limit Test for Determination of Selected Compounds from Teucrium spp . in Skullcap Materials in Commerce
Table 3: LOD
Parameter
Minimum Requirement
LOD
10 ppm
Table 4: Method Performance Requirements
Minimum Requirement (at detection limit)
Parameter
% Recovery
80 ‐ 110
RSD r
7
RSD R
11
Method Performance Requirements: Identification of Skullcap in Raw Materials, Skullcap-based Dietary Ingredients, and Dietary Supplements
Table 1: Method Performance Requirements
90% probability of identification with 95% confidence (33 correct identifications out of 33 samples known to contain skullcap).* See Validation Guidance in section 8 of this document.
Selectivity Study
*Some aberrations may be acceptable if the aberrations are investigated, and acceptable explanations can be determined and communicated to method users.
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