Setting new drug specifications

Identification Thresholds of organic impurities are limits above which an impurity should be identified in a new drug and this relates to the projected dosage of the new drug substance as in the following table.

Maximum Daily Dose	Reporting Threshold	Identification Threshold	Qualification Threshold
< 2g/day	0.05%	0.10% or 1.0mg per day intake (whichever is lower)	0.15% or 1.0mg per intake (whichever is lower)
> 2g/day	0.03%	0.05%	0.05%

for a copy of the full report visit the Onyx Scientific website here.