Vanillin, the primary component of vanilla extract, is a specialized metabolite found in concentrations ranging from 1.0% to 2.0% weight/weight (w/w) in vanilla pod extracts of Vanilla planifolia, Vanilla tahitensis, and Vanilla pompona, which stand as the principal origins of vanillin. It can be obtained through natural extraction from vanilla extract or synthesized chemically from guaiacol. In addition to these methods, bioengineering presents a contemporary approach to vanillin production, involving the use of genetically modified bacterial and fungal strains capable of converting a variety of substrates, such as ferulic acid, eugenol, iso-eugenol, and glucose, into vanillin. Vanillin has a role as a plant metabolite, an anti-inflammatory agent, a flavoring agent, an antioxidant, and an anticonvulsant. Vanilla allergenic extract is used in allergenic testing (1). Besides its industrial applications, vanillin possesses several beneficial effects for human health, such as antioxidant activity as well as to anti-inflammatory, antimutagenic, antimetastatic, and antidepressant properties.

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.


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$679 USD


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 Vanillin, 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