Characterizing your chemicals? What testing do you need?
By Kathey Robertson, Business Technical Manager
When characterizing your chemicals, ask yourself, what do I need from this testing?
Simple testing can be performed under ISO, and may only require a one technique evaluation, such as FT-IR spectroscopy. One test, one spectrum, and you are done.
But, if what you need is compliance in order to submit to a regulatory agency, whether it is the EPA, or the OECD, whether you need to comply with California Prop 65, or REACH, or GLP, you require a bit more…a lot more.
What do I have to do to comply?
For characterization for submission to the EPA, testing will need to conform to either FIFRA or TSCA. The data produced under these guidelines is designed to provide information about the environmental or health effects of a chemical substance. Typical chemical characterization may be accomplished using state of the art techniques such as FT-IR or NMR spectroscopy, as well as mass spectrometry to confirm molecular structure. Purity determination can be achieved by liquid or gas chromatography, along with KF titration for water content. All testing is performed using GLP.
For product or chemical registration in Europe, the regulation that the European Union enforces is Registration, Evaluation, Authorisation and restriction of Chemicals, or REACH. The REACH guidelines direct what testing has to be done for a material of interest. The OECD (Organisation for Economic Co-operation and Development), on the other hand, is a global entity comprised of 35 member countries, which has developed guidelines for the testing of chemicals using Good Laboratory Practices. Physical-chemical properties testing guidelines, according to the OECD, includes such techniques as UV-Vis spectroscopy, gel permeation chromatography, partition coefficient, and pH determination.
California’s Proposition 65 contains a list of “naturally occurring and synthetic chemicals that are known to cause cancer or birth defects or other reproductive harm.” These chemicals may be present in consumer products that range from pesticides to household cleaners, to foods and drugs. The Prop 65 initiative has set limits on how much of these chemicals may be present in products that are sold in the state of California. As a result, companies must provide evidence that their product does not exhibit the presence of those chemicals above the specification limits. Depending of the chemical of interest, testing can include elemental analysis for metals, liquid or gas chromatography with mass spectrometry.
Impact Analytical is a contract laboratory with extensive experience in analytical testing in a regulatory environment. With numerous rigorous inspections by both the U.S. FDA and U.S. EPA, as well as customer audits, our studies have been proven successful and our data reliable. Impact Analytical is a full service analytical laboratory, equipped with state-of-the-art instrumentation to meet your analytical testing needs.