OEL Fastrac Catalog

Senna, also known as Cassia, Fan Xie Ye, Alejandrina, Séné, Sennae, and Tinnevelly, consists of the pods (fruits) and leaves of Senna alexandrina P. Mill. (Leguminosae) used as a popular herbal laxative. Senna contains a complex mixture of bioactive constituents, including dianthrone O-glycosides, free dianthrones, and anthraquinones. Among these constituents, sennosides A and B are the primary compounds responsible for the laxative effect. Senna is a Food and Drug Administration (FDA)-approved over the counter (OTC) laxative used for the treatment of occasional constipation and also to clear the bowel before procedures such as colonoscopy. It is also employed in the management of opioid-induced constipation or in cases where bulk-forming or osmotic laxatives are ineffective. Senna leaves and fruits are commonly used as comminuted herbal substance. Additionally, there are some extracts which are also standardized on a defined content of hydroxyl anthracene glycosides. In the European Pharmacopeia, there is a standardized dry extract of senna leaves that contains not less than 5.5% and not more than 8.0% of hydroxyanthracene glycosides, calculated as sennoside B with reference to the dried extract. Senna is available as tablets, capsules, powder, and solution for oral administration and as suppository for rectal administration. Herbal preparations of senna are available a fluid extract, leaf, pod, oral solution, or tea for oral administration.

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.

Inquiries on monograph availability

The OEL/ADE monograph for Senna is under development.

You can contact us and let us know if you'd like to be notified when this document becomes available.

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