OEL Fastrac Catalog

Propolis is a honeybee product believed to have antioxidant, anti-inflammatory, anticancer, and antimicrobial effects. Raw propolis has been used in folk medicine since ancient times. In modern times, it is a starting raw material for manufacturing various extracts that can be used as active pharmaceutical ingredients. Among the biological activities of propolis extract, antimicrobial effects have been widely reported. Ethanolic extracts of propolis have been found to be effective against a broad range of bacteria, especially against gram-positive bacteria species. Propolis extract has been used as a nutritional supplement and in preparations for coughs, mouth disorders, and skin disorders. It has been used as an ointment for the relief of symptoms of herpes labialis. It is often found in topical formulations used to soothe minor skin irritations. Propolis extract has also been used in cosmetics and varnishes.

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.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

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 Propolis Extract, just click the ADD TO CART button.

HBEL

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