CPL offers test method development, validation, and testing services for elemental impurities in packaging components, raw materials, and finished products. Our cGMP laboratory is registered with the FDA and Health Canada (MRA with EU and Australia) and supports other global markets, including Japan.
Elemental impurities testing is a method of qualitatively and quantitatively analyzing packaging components, raw materials, and products for potentially toxic elements. In 2018, Elemental impurities testing became an FDA and Health Canada regulatory requirement. As a result, the pharmaceutical manufacturing industry must comply with these requirements and CPL is fully equipped to do just that. At CPL, our expert team of chemists will utilize state-of-the-art equipment to analyze your samples and provide cGMP documentation to support and present the data.
Get in touch and find out how CPL can fulfill your elemental impurities testing needs.