With decades of experience, Pharmacy Initiative 3 Limited have provided screening of a wide range of materials for pharmaceutical and excipient manufacturers as part of their risk assessment processes.
Over the years we have garnered a broad range of experience in elemental impurities analysis, and our highly experienced analysts are equipped with ICP-OES, ICP-MS, and ICP-MS-MS instruments to meet the often challenging requirements of the ICH Q3D guidelines, and the chapters adopted in the Ph Eur, USP and JP which replace the old heavy metals limit test.
We have developed generic methods which include spikes for each sample type to verify compliance with the requirements of the applicable General Chapters of Ph Eur, USP and JP.
Additionally, we also offer a full method development, verification or validation service should this be required – contact our Projects Team [link to Projects email] for more information.
Explore some of the techniques we commonly use for the testing for elemental impurities: