Elemental Analysis Utilizing Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
At Boston Analytical, Elemental Analysis, the process where a sample of material is analyzed for its elemental and sometimes isotopic composition, is performed via Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Used to analyze Excipients, Raw Materials, Drug Products or Finished Products, our analyses are screened incompliance with Elemental Impurity Methods USP <232> - Limits and USP <233> - Procedures.
We currently offer the following analyses for Water Soluble Materials:
- Elemental Impurities Testing
- Heavy Metals Testing
First introduced commercially in 1983, ICP-MS combines a high-temperature ICP source with a mass spectrometer. The ICP source converts the atoms of the elements in the sample to ions. These ions are then separated and detected by the mass spectrometer, detecting the metals and non-metals at very low concentrations.
ICP-MS has many advantages over other elemental analysis techniques such as optical emission spectrometry (ICP-OES), including:
- Superior sensitivity advantages over ICP-OES
- Detection limits for most elements are equal to, if not better than those obtained by other methods.
- Higher throughput
- The ability to handle both simple and complex matrices with a minimum of interferences due to the high-temperature of the ICP source
- Superior detection capability with the same sample throughput
- The ability to obtain isotopic information
- Identification in both qualitative (determining what elements are present), and quantitative (determining how much of each are present) form.
Boston Analytical has made the decision to provide ICP-MS analysis rather than ICP-OES in preparation of upcoming regulatory changes. Heavy Metals Analysis (USP <231>) will be replaced with Elemental Impurity Methods USP <232> and USP <233>. Additionally, it is anticipated that individual USP Metal Methods will be eliminated as well; these include USP <251> Lead, USP <211> Arsenic, and USP <261> Mercury. The effect of the elimination of these chapters to monographs that include them is current under review.
While the pharmaceutical industry adapts to these changing standards, Boston Analytical can provide ICP-MS analysis under the guidelines of USP <232> and USP <233> now. Excipients, Raw Materials, Drug Product, or Finished Product can all be analyzed in anticipation of the future regulations and determinations can be made as to future compliance with USP <232> and USP <233>.
Boston Analytical's staff of technical professionals maintains a strong understanding and proficiency associated with ICP-MS analysis. Our team of experienced Client Service Representatives and Project Managers can assist you with the development of a comprehensive ICP-MS analysis strategy that will result in reliable, high-quality data that will meet growing project needs, demands, and timelines.
For more information on how Boston Analytical can assist you with your next ICP-MS analysis, or for compliance with USP <232> and USP <233>, please contact us today.