Impurities in New Drug Substances:
“Any component of the new drug substance that is not the chemical entity defined as the new drug substance.”
(Source definition: ICH guidance for Industry-Q3A Impurities in New Drug Substances, June 2008)
Various impurities are defined:
Enantiomeric Impurity:
A compound with the same molecular formula as the drug substance that differs in the spatial arrangement of atoms within the molecule and is a non-superimposable mirror image.
See our services in regards to enantiomeric separation.
Extraneous Contaminant:
An impurity arising from any source extraneous to the manufacturing process.
Intermediate:
A material produced during steps of the synthesis of a new drug substance that undergoes further chemical transformation before it becomes a new drug substance.
Thresholds given in the ICH guideline:
Maximum Daily Dose1 |
Reporting Thresholds 2,3 |
Identification Threshold3 |
Qualification Threshold3 |
≤ 2g/day |
0.05% |
0.10% or 1.0 mg per day intake
(whichever is lower) |
0.15% or 1.0 mg per day intake
(whichever is lower) |
> 2g/day |
0.03% |
0.05% |
0.05% |
1 The amount of drug substance administered per day
2 Higher reporting thresholds should be scientifically justified
3 Lower thresholds can be appropriate if the impurity is unusually toxic
Contact us for elucidation of impurities.