In pharmaceutical products, elemental impurities can originate from various sources. They may be residual catalysts that were added intentionally during synthesis, or already present (e.g., processing equipment, container/closure systems, impurities in the drug product). Since elemental impurities can impact patients’ health and interfere with a drug’s efficacy, it is essential to tightly regulate their levels within acceptable limits in active pharmaceutical ingredients (APIs), medicinal products and raw materials. Our highly competent and experienced team of experts facilitate a risk-based control strategy ensuring adherence to current regulatory guidance.

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