Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance
LCGC North America
The FDA recently updated its 1987 guidelines for submitting samples and analytical data for method validation — a document that affects all analytical chemists working in the pharmacrutical industry. This article highlights the agency's recommendations of how to report and validate analytical data in all new drug applications.
Best of the Week: Food Analysis, Chemical Migration in Plastic Bottles, STEM Researcher of the Year
December 20th 2024Top articles published this week include the launch of our “From Lab to Table” content series, a Q&A interview about using liquid chromatography–high-resolution mass spectrometry (LC–HRMS) to assess chemical hazards in plastic bottles, and a piece recognizing Brett Paull for being named Tasmanian STEM Researcher of the Year.
Using LC-MS/MS to Measure Testosterone in Dried Blood Spots
December 19th 2024Testosterone measurements are typically performed using serum or plasma, but this presents several logistical challenges, especially for sample collection, storage, and transport. In a recently published article, Yehudah Gruenstein of the University of Miami explored key insights gained from dried blood spot assay validation for testosterone measurement.
Determination of Pharmaceuticals by Capillary HPLC-MS/MS (Dec 2024)
December 19th 2024This application note demonstrates the use of a compact portable capillary liquid chromatograph, the Axcend Focus LC, coupled to an Agilent Ultivo triple quadrupole mass spectrometer for quantitative analysis of pharmaceutical drugs in model aqueous samples.
