Please note, this OEL/ADE monograph also applies to trigonelline hydrochloride (CAS RN 6138-41-6). Plants contain several bioactive compounds that have biological effects on living organisms, tissues, or cells. Trigonelline, also known as N-methylnicotinate, is a plant alkaloid that was first extracted from fenugreek seeds (Trigonella foenum-graecum) (2, 3). Trigonelline is widely distributed in plants within the subclass Dicotyledoneae, having been identified in the dry seeds of some plants within the superorders Araliiflorae, Caryophylliflorae, Corniflorae, Fabiflorae, Gentianiflorae, Lamiiflorae, Loasiflorae, Magnoliflorae, Malviflorae, Myrtiflorae, Polygoniflorae, Primuliflorae, Ranunculiflorae, Rosiflorae, Rutiflorae, Santaliflorae, Solaniflorae, and Violiflorae.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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