Chemistry Reference
In-Depth Information
A.5.2 S
PecIfIcIty
Specificity is demonstrated by the separation of the peak of interest and any related
substances from each other and the absence of detectable peaks in the diluent blank
that would co-elute with any of the peaks of interest. Example chromatograms
should be provided.
A.5.3 l
IneArIty
And
r
Ange
The linearity is typically determined by regression analysis of the five concentra-
tions using the method of least squares. The correlation coefficient, coefficient of
determination,
y
-intercept, slope of the regression, and the residual sum of squares
are typically reported. The range of the method will be obtained from the linearity
analysis.
A.5.4 A
ccurAcy
Results will be calculated for each sample (accuracy/recovery). The percent recovery
in each sample will be determined based on the actual sample concentrations. The
mean, standard deviation, and %RSD are calculated and reported for each concen-
tration level.
A.5.5 P
recISIon
(r
ePeAtAbIlIty
And
I
ntermedIAte
)
Repeatability results are calculated from the six samples prepared by the first ana-
lyst. The mean, standard deviation, and %RSD will be calculated and reported.
For intermediate precision, the mean, standard deviation, and %RSD will be
calculated for each set of experiments (analyst A/column A/system A versus analyst
B/column B/system B).
A.5.6 r
obuStneSS
The effect (if any) of the variables tested will be determined by the system suitability
criteria.
A.5.7 d
egrAdAnt
lod
Visual observance of a chromatographic peak establishes the LOD. Example chro-
matograms should be provided.
A.5.8 d
egrAdAnt
loQ
The mean, standard deviation, and %RSD will be calculated from the analysis
of the six samples prepared at the 0.1% level. Example chromatograms should be
provided.
