Note - This also applies to alternate CAS RN 179118-73-1. Additionally, this monograph contains the pediatric ADE (pADE). Ambroxol Theophyllinacetate, also known as ambroxol acefyllinate or acebrophylline, is an equal molar combination drug of theophylline-7-acetate (also known as acefylline) and ambroxol. It is used for the symptomatic treatment of acute and chronic diseases of the respiratory system characterized by mucus hypersecretion including acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchial asthma or asthma like bronchitis, and pulmonary emphysema.
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 Ambroxol Theophyllinacetate, 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.