Since December 2014 ICH Q3D Guideline for Elemental impurities is in force. This guideline establishes that the pharmaceutical laboratories have to control the potential elemental impurities in the finished products and assess their potential toxicity based on the Permitted Daily Exposure (PDE).
After a risk assessment, the potential elemental impurities above the PDE have to be controlled in the finished product.
On the other hand, there are a lot of the raw materials (active substances and excipients) in which the analysis and quantification of several metals and other elements of the periodic table are needed for their release.
What is needed for these studies?
The quatification of the elemental impurities may be carried out by Atomic Absorption Spectroscopy (AAS) or by Mass Spectrometry Inductively Coupled Plasma (ICP-MS) or both.
What Netpharmalab offers to you…
At Netpharmalab, we offer the possibility of quantifying any element of the periodic table present in the raw materials or finished products by using ICP-MS technique which offers the advantage of low detection limits for most elements.