OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Hydrogenated phosphatidylcholine (CAS RN 97281-48-6; 97281-45-3; 92129-12-9). Phosphatidylcholine (PC) is the most abundant phospholipid in mammalian cellular membranes, bile, and lipoproteins. It is a constituent of lecithin. The injection of a PC and deoxycholic acid preparation is widely used as an alternative to liposuction for the reduction of subcutaneous (SC) fat. Phosphatidylcholine (PC) is also an ingredient of preparations that have been promoted for liver disorders, peripheral vascular disorders, hyperlipidemias, and fat emboli. Phosphatidylcholine (PC) is also used as a dietary supplement. Phosphatidylcholine (PC) is a component of several intravenous (IV) and oral drugs and is commonly found as an inactive drug ingredient. Phosphatidylcholine (PC) is already a standard therapy for respiratory-distress syndrome in premature babies with abnormally low PC lung-surfactant levels, and it is the major active ingredient of products used to prevent or treat respiratory distress syndrome.

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 Phosphatidylcholine, just click the ADD TO CART button.

HBEL

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