Isoflavone

Isoflavone is a class of polyphenolic compounds derived from the Fabaceae family with potential phytoestrogenic, cholesterol-reducing, chemotherapeutic and antioxidant activity. Isoflavone is a biologically active component of several agriculturally important legumes such as soy, peanut, green peas, chickpeas and alfalfa. Soybean is an exceptionally rich source of dietary isoflavones, where the average isoflavone content is 1 to 2 mg per gram. The main soy isoflavones are mostly present in glycosylated forms and include genistein, daidzein, and glycitein, which accounts for approximately 50%, 40%, and 10%, respectively, of the total soybean isoflavone content. The clinical benefits of soy proteins have been studied and demonstrated for many years, with some evidence of soy products associated with a reduced incidences of coronary heart disease, atherosclerosis, type II diabetes mellitus, and breast and prostate cancer. While existing data are consistent or inadequate in supporting most of the suggested health benefits of consuming soy proteins and isoflavones, the trials investigating isoflavone as a potential treatment for atrophy, menopause, and postmenopausal symptoms are ongoing.

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, an increased cost is charged.

Isoflavone

CAS Registry Number:
574-12-9
Trade names:
Isofem®, Fosteum®
Natural Health Product:
Yes
Cost:
$1,399 USD

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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. 10-12 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 Isoflavone, just click the ADD TO CART button.

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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing