Please note, this OEL/ADE monograph also applies to dihydrocodeine thiocyanate (CAS RN 84824-87-3), dihydrocodeine bitartrate (CAS RN 5965-13-9), and dihydrocodeine phosphate (CAS RN 24204-13-5). Dihydrocodeine is a schedule III controlled substance and is a mild analgesic indicated for mild to moderate pain. Dihydrocodeine has a potential for abuse and can cause physical and psychological dependence. Dihydrocodeine is a semi-synthetic narcotic analgesic related to codeine, with similar analgesic activity. Dihydrocodeine is metabolized to a highly active metabolite, dihydromorphine, which has a high affinity for mu-opioid receptors in the CNS. It acts on opioid receptors in the brain to reduce the perception of pain. LD50 values are reported as follows - rabbit oral 400 mg/kg, and mouse IV 80 mg/kg.
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), and to obtain the following information:
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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.