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.