Documentation

Product Protocol

Specifications

  • Assay Type Detection Kit
  • Sample Types API scavenging steps
  • Assay Duration 30 Minutes
  • Samples/Plate 41 in Duplicate
  • Readout Fluorescent, 520 nm Emission / 485 nm Excitation
  • Standard Curve
  • Description

    Assay Principle: The PdX™ Palladium (Pd) API Screening Detection Kit is designed to allow the rapid determination of the relative amounts of Pd present in active pharmaceutical ingredient (API) scavenging steps. Please read the complete kit insert before performing this assay

    Background: Many pharmaceutical processes use palladium (pd) compounds for synthetic transformations. Palladium (Pd) compounds are great catalysis of carbon-carbon and carbon-heteroatom coupling reactions. These reactions are popular for pharmaceutical processes, as they utilize a wide-range of functional groups to build complicated molecules. However, palladium-catalyzed reactions are problematic as the palladium can be retained in the isolated active pharmaceutical ingredient (API) product. Current FDA and EMEA regulations limit platinum group (Pt, Pd, Ir, Rh, Ru, Os) metal contamination, as a whole, to less than 5 ppm. Standard methods of Pd API evaluation require expensive instrumentation and highly trained scientists to operate. These methods also suffer from probe cross-contamination, and require scrupulous clean up methodologies.