Gaois

This is a static copy of data that is exported from IATE on an occasional basis. It should not be assumed that information provided about an entry here will always correspond to the current version of the entry in IATE. That current version can be checked by clicking on the link on the upper right hand side of each entry. More information »

1 result

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #690707

    IATE #3648708
    unqualifizierte Verunreinigung
    de
    Definition Verunreinigung, deren biologische Sicherheit unbekannt ist Reference COM-DE aufgrund der EN Definition
    unqualified impurity
    en
    Definition "impurity (substance that is not the active substance or an excipient in a medicinal product) whose biological safety is unknown" Reference "COM-Terminology Coordination and COM-EN, based on: EMA. ICH Topic Q 3 B (R2) Impurities in New Drug Products. Step 5. NOTE FOR GUIDANCE ON IMPURITIES IN NEW DRUG PRODUCTS (CPMP/ICH/2738/99) (9.12.2024), CPMP/ICH/2738/99, June 2006."
    Comment "An impurity can result from a chemical change in the active substance brought about during manufacture and/or storage of the new medicinal product by the effect of, for example, light, temperature, pH, water, or by reaction with an excipient and/or the immediate container closure system. In this case the impurity is a degradation product and its biological safety must also be known. The biological safety of metabolites of a medicinal product (which are also degradation products) must also be known and relevant data are normally included in safety and/or clinical studies."
    impureté non qualifiée
    fr
    Definition composant présent dans l'intermédiaire ou la substance active et qui n'est pas l’entité désirée, dont la sécurité biologique n’est pas connue Reference "COM-FR, d'après:Agence nationale de sécurité du médicament et des produits de santé (ANSM), Guide des bonnes pratiques de fabrication (19.12.2024), Glossaire, 2019"