OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Gemfibrozil sodium salt (CAS RN 114413-98-8) and Gemfibrozil succinimide (CAS RN Not Available). Gemfibrozil is used to treat high blood lipid levels and to prevent high blood lipid levels. Although gemfibrozil may slightly reduce total and low-density lipoprotein (LDL) cholesterol concentrations, use of gemfibrozil in patients with elevated triglycerides associated with type IV hyperlipidemia often results in significant increases in LDL; LDL concentrations are not significantly affected by gemfibrozil in patients with Type IIb hyperlipidemia (although HDL is significantly increased). The mechanism of this action is not completely understood but may involve inhibition of peripheral lipolysis; reduced hepatic extraction of free fatty acids, which reduces hepatic triglyceride production; inhibition of synthesis and increased clearance of VLDL carrier, apolipoprotein B, which also reduces VLDL production; and, according to animal studies, reduced incorporation of long-chain fatty acids into newly formed triglycerides, accelerated turnover and removal of cholesterol from the liver (stimulates incorporation of cholesterol precursors into liver sterols), and increased excretion of cholesterol in the feces.

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 Gemfibrozil, just click the ADD TO CART button.

HBEL

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