Page 47 - Pharmaceutical Solution for Pharma Analysis

Application No. G287
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n=1
n=2
n=3

n=4
n=5
n=6

Verification of Chromatogram Reproducibility (n=6)

Table 2 Analysis Results of Isopropyl Iodide
Retention Time (min) Peak Area (μV·sec) Peak Height (μV)
n=1 5.457 2500496 648329
n=2 5.456 2543782 660353
n=3 5.455 2554064 663212
n=4 5.456 2562147 662210
n=5 5.455 2555863 662440
n=6 5.454 2555863 661868
%RSD 0.024 0.886 0.859

Table 3 Analysis Results of the Internal Standard (Methylcyclohexane)
Retention Time (min) Peak Area (μV·sec) Peak Height (μV)
n=1 7.063 6907258 1778606
n=2 7.063 7072027 1824079
n=3 7.062 7118386 1832215
n=4 7.061 7145447 1838619
n=5 7.061 7110825 1827032
n=6 7.059 7078672 1835287
%RSD 0.020 1.232 1.219
Note: The above are reference values, not guaranteed values.

Reference
USP Stage 6 Harmonization (December 1, 2014)

First Edition: Apr. 2017
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