2018 March 16 SPDS

SMPR Key Points: Skullcap

3 SMPRs: • Quantification of Flavonoids • Limit Test • Identity

Method Performance Requirements: Determination of Select Flavonoids From Skullcap

Table 3:  Analytical Range & LOQ 

Parameter

Minimum Requirement

Analytical range (%, w/w) Limit of Quantitation (%, w/w)

1 ‐ 50

1

Table 4: Method Performance Requirements

Parameter

Minimum Requirement

% Recovery

92‐105

% RSD r

≤ 5

% RSD R

≤ 8