Echevarne Laboratory provides the determination of all metals included in the Guide EMEA/CHMP/SWP/4446/2000 simultaneously by ICP-MS (General Method 2.2.58 European Pharmacopoeia) and method validation for each matrix to analyze .
The European Medicines Agency (EMEA) has adopted a Guide of residues of metal of catalysts or reagents that may be present in Pharmaceutical Substances or Drug Use.
European Pharmacopoeia applies this guide to all substances for pharmaceutical use. The application of this control is to incorporate both substances on the market as those already present, with a moratorium for the latter which ends on September 1, 2013. Variability matrices, metals and concentrations that can be forced to take out a validation of the method for each array to be tested. We have 2 ICP-MS equipment art installed in a room classified.
Echevarne was a pioneer in our country to use this technique, which provides high selectivity and excellent detection limits. Our extensive experience using this technique in pharmaceutical samples can offer validation of the method and subsequent quality control with maximum guarantees. For cases that is necessary sample preparation, we have instrumentation to perform microwave digestion. We also offer the possibility of analyzing samples soluble in organic media.