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The examination of extractable and leachable substances (such as plasticizers, antioxidants, stabilizers and dyes) is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. In recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny by the regulators. When there is a change

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Curia

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Curia's experts work directly with regulators to participate in standard setting activities for ISO 10993-18 & ISO 10993-17.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Chemical Characterization

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