• HPLC-Based Strategies for Impurity Profiling and Validation in Standard Drug Analysis

    The control of pharmaceutical impurities is a fundamental objective in the development of drugs, focusing on the comprehension of the chemical structures of unidentified impurities. This understanding is essential for evaluating toxicological consequences and grasping the mechanisms of formation. API-related impurities, such as degradation and interaction, can affect drug product quality, safety, and efficacy. Classifying sources of impurities is essential for analytical method development and acceptance criteria. read more
  • An Interview With Andreas Eschbach

    How has AI acceptance evolved in the pharmaceutical sector, and what strategies have been most effective in overcoming resistance to AI adoption? read more
  • Why DSCSA Compliance in 2026 Hinges on Execution, Not Implementation

    After a decade of ramp-up, the era of DSCSA enforcement is no longer theoretical — it’s here. But as we move deeper into this phase of full compliance, the real story unfolds not just in establishing data feeds, but in the operational cracks that persist behind the scenes. read more
  • The Tariff Mitigation Toolkit

    For US-based pharmaceuticals companies attempting to minimize the effects of tariffs, one thing has become crystal clear: very little is crystal clear. read more