2018 March 16 SPDS
118 119 120
Table 3: Analytical Range & LOQ
Parameter
Minimum Requirement
Analytical range (%, w/w)
1 - 50
Limit of Quantitation (%, w/w)
1
121 122 123 124
Table 4: Method Performance Requirements
Parameter
Minimum Requirement
% Recovery
92-105
% RSD r
≤ 5
% RSD R
≤ 8
125 126 127 128 129 130 131
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