. 2020 Jul 1;22(4):89. doi: 10.1208/s12248-020-00473-w

Table 3.

DMF levels, reported testing results, and the impact of mass tolerance window on NDMA measurement

Sample # (Table 1)	DMF EIC peak area	Prior results (ng/mg)^a		Results from FDA replication study (ng/mg)^b
Sample # (Table 1)	DMF EIC peak area	FDA-1	Private laboratory	Mass tolerance ± 15 ppm	Mass tolerance ± 30 ppm
13	4.62E + 09	ND	0.276	ND	0.575
14	3.90E + 08	0.121	0.180	0.131	0.179
21	2.37E + 08	0.010	ND	ND	0.021

^ab”Prior results” are the values reported by the FDA-1 method or the private laboratory (see Table 1), Results from FDA study are obtained by FDA’s replication of the private laboratory’s method