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EC number: 220-449-8
CAS number: 2768-02-7
Concentration analysis of
formulation samples was performed at three concentrations, 10.00 mg/mL,
25.00 mg/mL and 75.00 mg/mL in study weeks 1, 5, 9, 13 and in the last
week of the study. The mean recoveries observed for the LD group were
between 91.3% and 99.0% of the nominal value, between 91.8% and 97.1% of
the nominal value for the MD group and between 88.5% and 96.3% of the
nominal value for HD group. The mean recoveries observed in the LD, MD
and HD groups were 95.8%, 94.5%, and 93.0% of the nominal concentration,
Nominal concentrations were
confirmed for all dose groups, as mean measured concentrations were
within acceptance criterion of 10%.
However, HD group sample no. 16 in
week 13 did not meet this criterion with a recovery of 88.5%. It was
decided that no reanalysis was necessary, since the mean value was still
within the acceptance criteria.
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