Please note, this OEL/ADE monograph also applies to the base molecule trehalose (CAS RN 99-20-7). Trehalose dihydrate is indicated for use as a flavoring agent or adjuvant, and is used as a formulation excipient in drug products. Trehalose is used as a texturizer, stabilizer, humectant, and sweetener in baked goods, beverages, confectionary, fruit jam, breakfast cereal, rice, and noodles. Trehalose acts as a stabilizer for proteins during freezing and drying. It also stabilizes phospholipid bilayers (e.g. liposomes) and more complex biological structures. In food processing therefore, trehalose has been used in the preparation of egg powder and dried fruits. Trehalose act as a cryoprotectant and is used in the production of surimi, frozen gelatin desserts, and premium ice creams. Trehalose appears to have a stabilizing effect not only during dehydration, but also during the rehydration of susceptible molecules.
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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