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.
