Elemental Impurities

We provide services of Elemental Impurities Analysis by ICP-MS according to ICH Q3D and European Pharmacopoeia and USP General Chapters <232>, <233> and <2232> for drug substances, excipients and drug products, including the 24 elements related in the ICH Q3D guideline and/or others:

  • Class 1: Cd, Pb, As, Hgmilestone.jpg
  • Class 2A: Co, V, Ni
  • Class 2B: Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt
  • Class 3: Li, Sb, Ba, Mo, Cu, Sn, Cr
  • Others: Al, B, Ca, Fe, K, Mg, Mn, Na, W, Zn…

We have established a standard operating procedure to carry out elemental impurity determination studies:

  • Semi-Quantitative Screening: specificity, accuracy (at one concentration level) and detection limits.
  • Limit Test Validation: specificity, accuracy (at three concentration levels), detection limit or detectability and repeatability, following the EP or USP requirements.
  • Quantitative Method Validation: specificity, linearity, accuracy (at three concentration levels), precision (repeatability and intermediate precision), quantification limits DSCF8032 còpia.jpgand range, following the EP or USP requirements.
  • Sample analysis: routine analysis for control strategy compliance.

We offer specific procedures, in case our procedure does not adapt to the requirements of our clients. We also assess on the extension of the risk analysis required in order to minimize the analytical workload.

Instrumentation:

We count with state-of-the-art ICP-MS instruments Agilent 7700​ and Agilent 7800 and 2 Ultrawave Milestone oven, with high capacity of sample digestion and acquisition. An Atomic Absorption instrument equipped with graphite furnace and hydride generator is available too. It can be used if a specific Pharmacopoeia monograph should be followed.

Contact form

Files must be less than 2 MB.
Allowed file types: pdf doc docx odt.