Elemental impurity testing – the perfect choice

Our analytical devices now include both AAS and ICP-OES instruments for precise elemental analysis.

The most recent addition to our analytical devices (No. 3445) is an ICP-OES instrument. This allows us to screen for harmful elements[GM1] [BF2] , including those listed in the ICH Q3D(R2) guideline, directly in migration extracts even in the presence of salts, buffers, and organic solvents. It is also sensitive enough to enable the detection of single elements in the sub-ppb range and is the method of choice for many compendial elemental impurity analyses, for example several extractable metals in EP 3.1.15.

Thus, our GMP-qualified device is the perfect choice for these tests. At the moment, OFI is also in the process of accreditation [GM3] [BF4] for the quantification of 48 different elements on this instrument and its performance is evaluated in an interlaboratory study with IFA-Tulln.