OEL Fastrac Catalog

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Dihydrocodeine, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.