Capsaicin

Capsaicin (trans-8-methyl-N-vanillyl-6-nonenamide) is one of the major irritant ingredients in capsicum and is widely used as a spice. Capsaicin is listed by the Council of Europe as a natural source of food flavoring. This category indicates that capsaicin can be added to foodstuffs in small quantities. Previously, capsaicin has been stated to be GRAS (Generally Recognized As Safe) (4, 5, 6). Topical creams containing capsaicin 0.025% and 0.075% are licensed in the UK for symptomatic relief of osteoarthritis, and post-herpetic neuralgia, respectively herbal medicine capsaicin should not be ingested in doses greatly exceeding amounts normally used in foods.

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.

Capsaicin

CAS Registry Number:
404-86-4
Brand name:
Not available
Cost:
$597 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), 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 monograph for this compound, just click the ADD TO CART button.

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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.

Affygility Solutions’s 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
  • Pharmatek Laboratories