Technology Impacts ICH Q3D Compliance Testing
A little known fact about testing drug products and excipients using USP 232/233 monographs for compliance to ICH Q3D Guidelines is that analytical interferences can be present resulting in non-compliance. Brooks Applied Labs has specialized in the testing of metals and metalloid compounds for over 30 years culminating in a robust understanding of what interferences may be present, both chemical and spectral, and how to mitigate them. An excellent example is that the introduction of oxygen gas to produce the AsO+ anoalogue during ICP-MS analysis has been established as the gold standard for arsenic quantitation. Does your CRO currently support this technology? BAL offers educational webinars to empower our pharmaceutical partners with information for making the most educated decisions possible. Contact us today to revolutionize the way your enterprise approaches supply chain CRO selection and experience the BAL difference.