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Table 1 Interim limits for NDMA and NDEA in sartan substances set by FDA

From: Development of a sensitive and stable GC-MS/MS method for simultaneous determination of four N-nitrosamine genotoxic impurities in sartan substances

Sartan

Maximum daily dose (mg/day)

Acceptable intake NDMA (ng/day)

Acceptable intake NDMA (ppm)

Acceptable intake NDEA (ng/day)

Acceptable intake NDEA (ppm)

Candesartan cilexetil

32

96

3.0

26.5

0.83

Olmesartan medoxomi

40

96

2.4

26.5

0.66

Irbesartan

300

96

0.32

26.5

0.088

Valsartan

320

96

0.3

26.5

0.083