Strategies for Elemental Impurities Testing in Pharmaceuticals


A talk from the PerkinElmer Chemicals Summit – Pharmaceutical Chemicals Symposium

With regulatory requirements, validation protocol, and data integrity all being in the forefront, it is important to equip the laboratory with more than just analytical equipment. In this presentation, Aaron Hineman, Inorganic Product Line leader discusses the tools, resources and knowledge that a total solution approach offers to USP testing to enable laboratories to analyze samples faster and ensure compliance with regulations on electronic records and signatures. Aaron will discuss:

  • USP Chapters 232 and 233 and ICH Q3D
  • 21 CFR Part 11 requirements and compliance
  • PerkinElmer’s offerings to streamline elemental impurity testing
  • Syngistix software to ensure data integrity and compliance

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