OEL Fastrac Catalog

Lupin extract is an aqueous extract from the germinated seeds of sweet Lupinus albus. Lupines are often classified as either bitter or sweet. Bitter lupines, such as the lupini beans consumed in Europe, have high concentrations of alkaloids (mainly sparteine), which make them bitter to taste. A debittering process is required before consumption. Sweet lupines, such as those grown in Western Australia, have low levels of alkaloids (mainly lupanine). Lupine seeds/beans have been traditionally used as a high protein feed for livestock. Some lupine species are grown for their aesthetic properties. The Texas state flower (Bluebonnet) is a wild lupine. Some species are now used for human consumption. These species have been selectively bred for lower alkaloid content and are referred to as "sweet" or "semisweet" lupines. Lupine seeds are consumed in the Middle East, Spain, and southern Europe as an appetizer and are a good source of protein. Aqueous extract from the germinated seeds of sweet Lupinus albus as a fungicide on strawberry and tomatoes.

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

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HBEL

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