Impurities

IMPURITIES

Any chemical substance present in a drug substance or pharmaceutical product that is not the Active Pharmaceutical Ingredient nor an excipient of formulation is considered an impurity, independently of its origin.

Impurities present in a drug can affect its efficiency and its safety, therefore studies of impurities are currently one of the most important in pharma to meet regulatory requirements.

Thus, the identification, quantitation, qualification and control of impurities are a critical part of the drug development process. AMSbiopharma regularly develops impurity related studies, including quantitation, structural characterization and, if needed, also isolation and synthesis.

Impurity Profiling

Structural Determination

Isolation of Impurities

Quantitation

Elemental Impurities

Extractables and Leachables

Residual Solvents

Genotoxic Impurities

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