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In the previous Amsa TM the impurities cited and limited were:
1,3-Dimethyladamantane (Related compound A)
3-methyl-adamantamine
l-Chloro-3,5-dimethyladamantane (Related compound C)
l-Bromo-3,5-dimethyladamantane (Related compound D)
Acetyl memantine
n.m.t.
0.15% (Amsa limit)
n.m.t.
0.15% (Amsa limit)
n.m.t.
0.10% (Amsa limit)
n.m.t.
0.10% (Amsa limit)
n.m.t.
0.15% (Amsa limit)
Related compound С and D were not indicated in the Amsa specifications, but the method used was able to detect them and in the TM was present the rRT to identify these peaks, but they were considered and limited as unknown impurity, (n.m.t.
0.10%)