Determination of Eight Nitrosamine Impurities

The dream state If we lived in an ideal world, it would be possible to unambiguously identify metabolites using a single analytical experiment. This analytical technique would need to be efficient and easily generate the information needed from a routine assay that is also robust, enabling confident decision-making during drug discovery. At SCIEX, we believe that metabolite identification using the ZenoTOF 7600 system gets close to this dream state.

Read about a material-sparing strategy for developing spray-dried intermediates (SDIs) and their tablet formulations, enhancing bioavailability for poorly soluble active pharmaceutical ingredients (APIs), using erlotinib as a case study. By integrating formulation mapping, polymer screening, and compact screening, the approach enables rapid risk identification and informed decision-making for first-round tablet formulations.

As a leader responsible for metabolite identification in your organization, what keeps you awake at night? SCIEX can give you peace of mind by helping you . . .

Here we discuss a software-assisted drug metabolite identification and characterization workflow. The approach allows scientists to have increased confidence in the process.

Many consumers trust that a Certificate of Analysis (COA) guarantees product safety, but without strict regulatory oversight, that’s not always the case. This white paper provides insights into what consumers and businesses should look for in a truly safe, high-quality, and consistent product.

The regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.