Please note, this OEL/ADE monograph also applies to Mebeverine hydrochloride (CAS RN 2753-45-9). Mebeverine, as mebeverine hydrochloride, is an orally bioavailable reserpine derivative and anticholinergic agent, with spasmolytic activity. Mebeverine is indicated in the management of the irritable bowel syndrome (irritable colon, spastic colon, functional bowel disorders, spastic constipation and nervous diarrhea). It is used to treat the symptoms of this condition (abdominal pain and cramps, persistent, nonspecific diarrhea), with or without alternating constipation and flatulence.
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:
To order an OEL/ADE monograph for Mebeverine, just click the ADD TO CART button.
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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.