Due to the increasing attention focus on the safety of pharmaceutical products, the evaluation of contamination by trace metals has become more important. We provide services on testing of elemental impurities corresponding to ICH-Q3D using ICP-AES (Atomic emission spectrometry) or ICP-MS.
These services are in compliance with global regulations of US, EU, and Japan or your procedure requests. We offer services on not only identification and quantitation of inorganic elements in samples (raw materials, intermediates, APIs, and pharmaceutical products) but also test method development and validation. In case there are any organic substances interfering the measurement, we perform wet digestion using a microwave pretreatment device.
ICP-MS can analyze about 70 types of inorganic elements at the ppt. level, except halogen and rare gases. We use this method to quantitate heavy metals to correspond to ICH-Q3D.
ICP-AES measures the emission intensity at a specific wavelength of each element, and ICP-MS measures the counts of ions of each element.
We also have an LC-ICP-MS connected with HPLC to separate and quantitate elements based on chemical speciation. If you are looking for a solution in drug discovery research, please contact us.
Yellow parts are the measurable elements.
Our Experiences in ICP Analysis
- Palladium purity testing in drug substances
- Investigation of the cause of precipitation in manufacturing processes
- Quantitative analysis of arsenic in pharmaceutical products