Research and Development Support
Testing support for product research and development.
Impact Analytical provides analytical testing to support drug product and medical device research and development. Impact’s scientists have a combined 300+ years of experience in analytical chemistry. We have experience developing material specific assays and methods for use in research support that can subsequently be utilized for final product testing. Our dedicated R&D support teams partner directly with the client to provide chemical and material testing support that ensures timeline integrity. This approach allows the client to access our experience and regulatory knowledge directly, saving time and budget.
Impact Analytical provides focused support for API development, assay and impurities methods development, container closure material selection, stability, drug or material compatibility, extractables, accelerated stability, and medical device material selection. This support can be leveraged from development through preclinical, phases I and II, and final product manufacture.
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Elemental and Trace Metals Analysis
Impact Analytical provides trace metals and ultra-trace elemental analysis services using state-of-the-art inductively coupled plasma atomic emission spectroscopy (commonly known as ICP-OES or ICP-AES), and inductively coupled plasma mass spectrometry (ICP-MS). ICP-OES analysis is an excellent technique for identifying and quantifying elemental constituents in various sample matrices including polymers, pharmaceuticals, chemicals, solutions, plastics, metals, and consumer products. ICP-MS analysis provides ultra-trace elemental analysis to identify and quantitate elements down to the sub parts-per-billion range, while utilizing a dynamic collision cell to eliminate troublesome interferences.
With our ICP-MS and ICP-OES capabilities, we can identify and quantify trace metals at percentage levels, as well as parts per million (ppm), parts per billion (ppb), and parts per trillion (ppt) levels by using established sample preparation techniques and analyses. We offer full sample digestion capabilities, including aqua regia, HF, as well as the use of hot plate digestion and microwave digestion for hard-to-digest materials.
Impact Analytical quality program is certified to the ISO 9001:2008 system standard. Don’t have a method to use? Our experienced staff can perform method development as well as method validation to meet your specific needs. Our cGMP and GLP-compliant laboratories can administer elemental testing by ICP-OES and ICP-MS in compliance with ICH Q3D and USP Chapters <232> and <233>.
Examples of ICP analysis services our lab can provide:
Trace metals analysis
- Ultra-trace metals analysis
- Heavy metals analysis
- Determination of Silicon
- Impurity testing
- Package testing for support of Extractables & Leachables studies
- USP 232 and 233 testing
- Analysis of Wax and Fragrance Samples
- Lead content
We can detect and measure the following trace and ultra-trace metals:
Determination of Nickel and Lead in Wax Samples by ICP-MS
August 4, 2016
By Barbara Pavan, Ph.D. and Lucia Gardey, Technical Co-op
Problem: Analysis of unknown white material developing on dashboards
Solution: ICP Analysis - read full case study