World Pharma Today recently featured Inorganic Ventures in the article, "Trace-Level Testing, Validation Pressure, and the New Demands on Pharma Labs," written by Brian Alexander, PhD, president of Inorganic Ventures, examining how pharmaceutical labs are adapting to tighter impurity thresholds and faster development timelines. (worldpharmatoday.com)
The article explores how sample preparation, digestion, calibration alignment, traceability, and method validation all influence whether elemental impurity data can withstand regulatory scrutiny — and why laboratories rely heavily on certified reference materials and calibration standards to establish traceable instrument response. (worldpharmatoday.com)
The piece discusses how sample preparation and digestion can shape whether elemental impurity results hold up to regulatory scrutiny, and features additional perspective from Suresh Ramachandran, an analytical chemist with over 20 years of experience in pharmaceutical elemental analysis, on the traceability and documentation manufacturers must provide during regulatory filings. (worldpharmatoday.com)
The article also highlights how validated methods depend on consistency over the product lifecycle, and why calibration standards, traceability, and documentation become increasingly critical as impurity thresholds tighten and regulatory scrutiny increases. (worldpharmatoday.com)
Read the full article here:
Trace-Level Testing, Validation Pressure, and the New Demands on Pharma Labs