Reference Standard Qualification
MRIGlobal maintains a repository of reference standards for the complete characterization of our clients’ API and drug product.
Reference material for impurities and the API are stored according to client specifications in a controlled, monitored, and alarmed environment. Retest and re-qualification of the standards are also performed as required by our clients.
Capabilities
Testing may include identity verification, HLPC or GC assay, impurity verification by LC/MS, moisture content, or appearance.
MRIGlobal provides a certificate of analysis (CoA) with comprehensive testing according to cGMP requirements based on the validated instrumental analysis.
Our Staff
While industry turnover remains high, MRIGlobal’s team boasts an average of 13 years of experience within our organization.
We take on the unusual and the challenging every day and put our skills to work analyzing the complexities of drug formulation, verifying reference standards of the identified impurities, and providing storage and worldwide distribution. We’re passionate about our work.
Work with us
MRIGlobal looks forward to contributing our expertise where it matters most.
Use our Project Quote Tool to see if MRIGlobal can help advance your next project.