Please note, this OEL/ADE monograph also applies to bromhexine hydrochloride (CAS RN 611-75-6). Bromhexine is indicated for the treatment of excess mucous in the respiratory system. Following oral administration, bromhexine has increased sputum volume and reduced the thick stickiness of bronchial secretions in chronic bronchitis patients. The drug has been reported to induce the breakup of mucous proteins through hydrolysis and stimulate activity of the ciliated lining of the respiratory system to move mucous out towards the mouth.
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 Bromhexine, 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.