Please note, this OEL/ADE monograph also applies to promethazine hydrochloride (CAS RN 58-33-3). Promethazine is indicated for the treatment of allergy, motion sickness, nausea & vomiting, postoperative pain and as a sedative as well as an adjunct to anesthesia. Promethazine is a phenothiazine derivative that competitively blocks histamine H(1) receptors without blocking the secretion of histamine. The drug has sedative, anti-motion sickness, antiemetic, and anticholinergic effects but it has no dopaminergic action due to a structural difference with other phenothiazines.
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 Promethazine, just click the ADD TO CART button.
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Affygility Solutions’s 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.