Elemental assay & impurity testing

Capabilities

We offer both targeted and screening trace and heavy metals analysis from ppm to ppt detection levels, depending on the technique used and the sample matrix. We can perform reliable and accurate analysis using ICP-OES and ICP-MS in accordance with ICH (ICH Q3D Elemental Impurities testing) and USP guidelines. We offer speciation analysis for As, Hg and other elements to ensure compliance and to help investigate process chemistries and reaction studies.

Sample preparation

  • Wet chemical digestion
  • Fusion
  • Microwave digestion
  • Accelerated solvent extraction
  • Sonification


Techniques

  • Inductively Coupled Plasma with Optical Emission Spectrometry (ICP-OES) - Thermo iCAP7600 Duo
  • Inductively Coupled Plasma with Mass Spectrometry (ICP-MS) - Agilent 7700x and Agilent 7900


Applications

  • Full metals screening - quantitative and qualitative
  • Targeted metals analysis
  • Heavy Metals to USP 232/233
  • Monograph testing
  • Active/Drug substance testing
  • Finished product testing
  • Raw materials testing
  • Stability and release testing
  • Extractable and leachable testing (including Silicone oil leachable testing)
  • Metal speciation
  • Contamination analysis