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