Impurity/Degradation Product Identification
What is it?
We identify drug impurities and degradation products that typically arise during synthesis. This is a vital step in the drug development process because highly reactive impurities have the potential to react with DNA.
How does it work?
We perform impurity and degradation product identification through mutagenicity assessments. A variety of software tools can be employed to perform the necessary assessments to comply with ICH M7 guidelines.
Why choose Arcinova?
Our flexible approach allows us to provide this service both on a stand-alone basis or as part of an integrated service. If a complete identification service is required we can combine expertise with our on-site analytical team.