Table 1.

Thresholds for impurities in new drug products [ICH, 2006].

	Reporting thresholds
Maximum daily dose		Threshold
≤ 1 g		0.10%
> 1 g		0.05%
	Identification thresholds
Maximum daily dose		Threshold
< 1 mg		1.0 % or 5 µg TDI, whichever is lower
1–10 mg		0.5% or 20 µg TDI, whichever is lower
> 10 mg–2 g		0.2% or 2 mg TDI, whichever is lower
2g		0.10%
	Qualification thresholds
Maximum daily dose		Threshold
< 10 mg		1.0 % or 50 µg TDI, whichever is lower
10–100 mg		0.5% or 200 µg TDI, whichever is lower
> 100 mg–2 g		0.2% or 3 mg TDI, whichever is lower
2g		0.15%

TDI, total daily intake