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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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AMRI

DPT Laboratories, Ltd

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UNITED STATES

Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

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- Service Details

AMRI's experts help you determine and quantify the impact of potential genotoxic impurities on drug efficacy through toxicological risk.

- Directory Listing

Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Impurities

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