Accredited to ISO 17025 standards, WMINOLAB operates as a trusted global partner in the Determination of Elemental Impurities studies, leveraging its team of experts and state-of-the-art instrumentation.
Elemental impurities are substances that provide no therapeutic benefit to the patient and must be controlled within acceptable limits in pharmaceutical products.
Risk assessment should address the potential sources of elemental impurities in the drug product.
These impurities may originate from elements intentionally added during the manufacturing of active pharmaceutical ingredients (APIs), excipients, or other components (e.g., catalysts), as well as from manufacturing equipment or container-closure systems.
Limits are established by regulatory authorities such as the FDA, the International Council for Harmonisation (ICH), and the United States Pharmacopeia (USP), based on permitted daily exposure (PDE) values to ensure optimal patient safety
At WMINOLAB, elemental impurity studies are conducted in accordance with the ICH Q3D Guideline.