Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #680004

    IATE #1554037
    próifíl eisíontais Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Is le foirmliú dáileoige béil soladach tobscaoilte nó le tuaslagán béil amháin a bhainfidh an t-athrú agus ní spreagfar athrú díobhálach ar phróifíl eisíontais cáilíochta ná ar phróifíl eisíontais cainníochta ná ar airíonna fisiciceimiceacha.' Reference "Rialachán Cur Chun Feidhme (AE) 2021/17 lena mbunaítear liosta modhnuithe nach n-éilíonn measúnú i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0017/GA"
    impurity profile
    en
    Definition "identity of impurities, quantity of impurities and source of impurities as well as description of unidentified impurities present" Reference "COM-Terminology Coordination, based on: - EMA. 'ICH Topic Q 3 B (R2) Impurities in New Drug Products' (17.2.2023). June 2006 CPMP/ICH/2738/99- PharmTech.com. 'Evaluating Impurities in Drugs (Part III of III)' (17.2.2023)"
    Comment Concerning pharmaceutical products, there are synthesis-related impurities, formulation-related impurities, dosage form-related impurities, method-related impurities, environmental-related impurities, impurities on aging, metabolite impurities.