For several years, NAMSA has offered metal analysis by Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). This method is a type of emission spectroscopy that uses inductively coupled plasma to produce excited atoms that emit electromagnetic radiation at wavelengths characteristic of a particular element. The wavelengths are measured by the instrument using an optical spectrometer which diffracts, separates, and integrates the individual wavelengths whose abundance (intensity) is proportional to concentration. One downside of ICP-OES is that there are many overlapping spectral interferences and high background emissions from the plasma itself, which can increase detection limits.
As NAMSA continues to make vast improvements in our facility and instrumentation, we are proud to announce that NAMSA will now also be offering Inductively Coupled Plasma Mass Spectrometry (ICP-MS). With ICP-MS, the ions are excited by the plasma and then extracted through a series of cones into a mass spectrometer, usually a quadrupole. The ions are separated on the basis of their mass-to charge ratio and a detector receives an ion signal proportional to the concentration. Due to the sensitivity of the MS detector, ICP-MS can be used to quantitate up to 1000 times lower concentrations than ICP-OES.
With the addition of the new instrument we have also expanded the number of elements screened for when performing a trace level analysis. The following table identifies the differences in the two test methodologies/instrumentation:
|ICP-MS||Quantitation Limit (ppm)||ICP-OES||Quantitation Limit (ppm)|
|Aluminum (Al)||0.01||Aluminum (Al)||1.0|
|Antimony (Sb)||0.01||Antimony (Sb)||0.50|
|Arsenic (As)||0.01||Arsenic (As)||0.50|
|Cadmium (Cd)||0.01||Cadmium (Cd)||0.25|
|Chromium (Cr)||0.01||Chromium (Cr)||0.25|
|Cobalt (Co)||0.01||Cobalt (Co)||0.25|
|Copper (Cu)||0.01||Copper (Cu)||0.25|
|Lead (Pb)||0.01||Lead (Pb)||0.50|
|Magnesium (Mg)||0.01||Magnesium (Mg)||1.0|
|Manganese (Mn)||0.01||Manganese (Mn)||0.25|
|Molybdenum (Mo)||0.01||Molybdenum (Mo)||0.50|
|Nickel (Ni)||0.01||Nickel (Ni)||0.25|
|Selenium (Se)||0.01||Selenium (Se)||1.0|
|Strontium (Sr)||0.01||Strontium (Sr)||0.25|
|Tin (Sn)||0.01||Tin (Sn)||0.50|
|Titanium (Ti)||0.01||Titanium (Ti)||0.25|
|Vanadium (V)||0.01||Vanadium (V)||0.25|
|Zinc (Zn)||0.01||Zinc (Zn)||1.0|
|Zirconium (Zr)||0.01||Zirconium (Zr)||0.50|
ICP-MS has become a very popular state-of-the-art assay used in chemical characterization necessary to quantitate metals/elements used in medical devices. ISO 10993-18 “Biological Evaluation of Medical Devices – Chemical Characterization of Materials” identifies use of the ICP-MS assay as one method for identifying and quantitating metals/elements.
In additional to standard extractables studies, the ICP-MS allows us greater flexibility in performing leachable studies. While NAMSA’s Validation Services group has significant expertise in method development and validation, the addition of the mass detector enhances our ability to work with a myriad of matrices ranging from organic solvents to a variety of drug products and drug product vehicles.
As part of the ICP-MS upgrade, we also have introduced microwave digestion capabilities. The microwave digestion apparatus is used for preparation of certain samples which can then be subsequently analyzed by ICP-MS. Samples (such as tissues) are efficiently and effectively prepared by microwave digestion prior to analysis of elements by ICP-MS.
NAMSA will continue to offer ICP-OES analysis, as it especially useful for determining higher (i.e., assay) levels of metals. We are also sensitive to our clients need to utilize previous testing methods for stability studies or other previously established methods.
If the element you need analyzed is not on the above list, it does not mean NAMSA cannot analyze for it. It only means it was not included in this specific screening method. Additional elements can be offered on an as needed basis. To learn more about how the ICP-MS testing can help with your R&D studies, commercial products and combination devices, please reach out to us at namsa.com/contact-us.