Lab Manager recently featured Inorganic Ventures in the article, "Trace-Level Testing, Validation Pressure, and the New Demands on Pharma Labs," examining how pharmaceutical labs are adapting to tighter impurity thresholds and faster development timelines.
The article explores how regulatory frameworks like USP <232>, USP <233>, and ICH Q3D have intensified the industry's focus on elemental impurity testing, pushing pharmaceutical laboratories toward increasingly sensitive workflows — particularly ICP-MS and ICP-OES systems capable of trace-level detection.
Featuring insights from Brian Alexander, PhD, president of Inorganic Ventures, the piece discusses how sample preparation, digestion, and calibration alignment can shape whether elemental impurity results hold up to regulatory scrutiny — noting that instrumentation alone can't compensate for an uncontrolled prep workflow.
The article also highlights how validated methods depend on consistency over the product lifecycle, meaning the standards and reagents selected during development often become part of a method's long-term foundation — and why traceability, documentation, and reliable calibration standards become increasingly critical as impurity thresholds tighten. (labmanager.com)
Read the full article here:
Trace-Level Testing, Validation Pressure, and the New Demands on Pharma Labs