The European Medicines Agency (EMA) has created a Guideline on the specification limits for residues of metal catalysts or metal reagents that may be present in pharmaceutical substances or in drug products.
The European Pharmacopoeia defines requirements for the qualitative and quantitative composition of medicines, the tests to be carried out on medicines and on substances and materials used in their production.
The variability of matrices, metals and concentrations that can be found requires to carry out a validation of the method for analyzing each matrix.
Echevarne offers the determination of all metals included in the Guideline EMEA/CHMP/SWP/4446/2000 simultaneously though the ICP-MS (Inductively Coupled Plasma Mass Spectrometry) technique, as well as the validation of the method for each matrix to analyze. We have two ICP-MS equipment of last generation installed in a classified room.
Echevarne was the Spanish Pioneer on using this technique, which offers a great selection and limits of detection unsurpassable.Our extensive experience with the use of this technique on pharmaceutical samples allows to offer the validation of the method and the QA with the maximum guaranties.