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EC number: 619-437-9
CAS number: 99474-22-3
The retention times which were recorded for the reference items
are presented in the following table.
Table9.1‑a Retention Times (RT) Reference Items
For each reference item, the calculated capacity factors are
presented in the following table.
Table9.1‑b Capacity factors Reference Items
Retention TimeStandard Deviation
Retention TimeRelativeStandard Deviation
The values for log k and log POWof the reference
items are presented in the following table:
Table9.1‑c log k and log POWof
Dead time is 1.440 ± 0.000 minutes, with RSD (relative standard
The RSD of the retention times of the reference items lay all
below 0.32 %.
Equation of the regression:
log k = 0.3628 * log POW– 0.8112
with a coefficient of determination r2= 0.944
The retention times of the test item are presented in the
Table9.2‑a Retention Times (RT) Test Item
The calculated values are presented in the following table:
Table9.2‑b Capacity Factor, log Capacity Factor, log POWTest
Relative Standard deviation
log POWwas calculated from the capacity factor as
log POW= (log k + 0.8112) / 0.3628
The test item shows one peak. Using the correlation log k / log POW,
the log POWof test item was calculated as 2.774 ± 0.000
(mean ± standard deviation).
The validity criteria and results are presented in the following
Table9.3‑a Validity Criteria and Results
Range (Max – Min. log POW)
0.30 - 3.60
Variations in the retention times of reference items and test
item are very small. Therefore, a stable configuration of the
HPLC-column can be assumed.
The correlation log k/log POWis good: the coefficient
of determination r2was calculated with 0.944. This value
was considered as sufficiently high to use the calibration function
for the determination of the log POWof the test item.
Using the correlation log k / log POW,the
log POWof the test item was calculated as2.774
± 0.000(mean ± standard
Therefore, the log POWof the
test item is stated as2.8(mean)at
a temperature of 25 ± 0.5 °C and a pH value of 7.
No observations were made which might cause doubts concerning
the validity of the study outcome.
A GLP compliant study has been conducted according to the OECD
TG 117 guideline in order to determine the log Pow of the test item.
The study was performed using a HPLC with a C18 column. Seven
reference items with different retention times and thiourea for the
determination of the dead time were used to produce a calibration
curve, since retention time on hydrophobic columns and POW are
correlated. The reference items were chosen based on the results of
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