Rhodiola rosea

The constituents of Rhodiola rosea (R. rosea) root extract include phenylalkanoids, essential oil, monoterpene derivatives, cyanogenic glycosides, proanthocyanidins, flavonolignans, flavonoids, and phenolic acids. Rhodiola rosea root extract contains more than 140 active ingredients, with the two most potent being rosavin and salidroside. Therefore, chemical and physical characteristics are not applicable. Rhodiola rosea belongs to the Crassulaceae family and has a long history as a folk remedy for enhancing physical and emotional endurance. Rhodiola (also known as arctic root or golden root) is an herb that grows in the cold, mountainous regions of Europe and Asia. The scientific name is Rhodiola rosea. Its roots are considered adaptogens, meaning they help the body adapt to stress when consumed. People in Russia and Scandinavian countries have used Rhodiola for centuries to treat anxiety, fatigue, and depression.

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.

Rhodiola rosea

CAS Registry Number:
N/A
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 Rhodiola rosea, 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