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
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