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.
Background
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.
CPL will help to:
- Support your project from inception to completion
- Understand and manage the challenges from USP <233> and <232>, EP, and ICH Q3D
- Conduct a Risk Assessment based on your excipients, API, packaging components and manufacturing equipment to support regulatory applications
- Determine if quantitative or qualitative testing is required
- Utilize a customized approach to screen elemental impurities
- Establish limits in drug products to adhere to regulatory USP and EP requirements
CPL provides:
- Experience in method development, validation, transfer, and routine testing for elemental impurities in packaging components, raw materials, excipients, APIs, and drug products
- Verification of Pharmacopeial methods
- Study transfer from different analytical technologies to ICP-MS (from ICP-OES or AAS)
- Experience with a variety of different sample types and complex sample matrices including, oral, parenteral, inhalation, and topical products
- Investigative analysis – an element might be linked to a product failure i.e., amalgamation or identification of metal particles
- Evaluation of leachable-extractable profiles on both manufacturing and packaging contact materials to support USP <1663>, <1664>, <661.1> and <661.2> requirements
- Determination of trace metals in water and waste by EPA (Environmental Protection Agency)
- Product reverse engineering support
- Closed vessel microwave digestion
- Hydrofluoric Acid testing capabilities
Contact us.
Get in touch and find out how CPL can fulfill your elemental impurities testing needs.