World Pharma Today featured Inorganic Ventures in its September 2026 print issue (Vol. 12, Issue II), "Proving: From Analytical Rigour to Patient Impact," with a byline article from Brian Alexander, PhD, president of Inorganic Ventures, titled "Trace-Level Testing, Validation Pressure, and the New Demands on Pharma Labs."
The article examines how tightening regulatory frameworks — including USP <232>, USP <233>, and ICH Q3D — are pushing pharmaceutical laboratories toward increasingly sensitive analytical workflows, particularly ICP-MS and ICP-OES systems capable of trace-level metal detection.
The piece discusses why sample preparation and digestion often determine whether elemental impurity results can withstand regulatory scrutiny, and includes additional perspective from Suresh Ramachandran, an analytical chemist with more than 20 years of experience in pharmaceutical elemental analysis, on the importance of traceable, well-documented standards throughout a method's lifecycle.
The article closes by emphasizing that as impurity thresholds tighten and regulatory scrutiny increases, supplier selection is increasingly tied to whether certified reference materials can support validated methods over time — through traceability, purity, stability, documentation, and reliable technical support.
Read the full September 2026 issue of World Pharma Today here: