OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to morphine hydrochloride (CAS RN 52-26-6), morphine sulfate (CAS RN 64-31-3), morphine hydrochloride trihydrate (CAS RN 6055-06-7), morphine tartrate (CAS RN 302-31-8), and morphine sulfate pentahydrate (CAS RN 6211-15-0). Morphine sulfate is an opioid analgesic indicated for treating many diverse types of pain. Morphine is also indicated for many various conditions. Morphine sulfate is a pure opioid agonist, selective to the mu receptor, with primary actions in the brain through transitory stimulation prior to depression. In the CNS, it promotes analgesia and respiratory depression by decreasing brain stem respiratory centers response to carbon dioxide tension and electrical stimulation. It also decreases gastric, biliary and pancreatic secretion, induces peripheral vasodilation and promotes opioid-induced hypotension due to histamine release.

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 Morphine, just click the ADD TO CART button.

HBEL

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