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COMPENDIUM

Perform Compliant USP 232 and ICH Q3D Elemental Analysis 

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Elemental impurities in pharmaceutical formulations can interfere with drug efficacy or have a toxic effect on the patient. Regulators have issued guidelines—such as ICH Q3D, USP 232 and USP 233 Elemental Impurities.

Download this compendium to learn how to monitor a range of metal elemental impurities in pharmaceutical materials using elemental analysis techniques such as:

  • ICP-OES
  • ICP-MS or,
  • AAS

As well as tips to ensure specific validation requirements described in the guidelines are met.