OEL Fastrac Catalog

Chamomile (Matricaria recutita, also known as Matricaria chamomilla L. and Chamomilla recutita) is one of the important medicinal herbs native to southern and eastern Europe. It is also grown in Germany, Hungary, France, Russia, Yugoslavia, and Brazil. It was introduced to India during the Mughal period, and now it is grown in Punjab, Uttar Pradesh, Maharashtra, and Jammu and Kashmir. The plants can be found in North Africa, Asia, North and South America, Australia, and New Zealand. Hungary is the main producer of the plant biomass. In Hungary, it also grows abundantly in poor soils and it is a source of income to poor inhabitants of these areas. Flowers are exported to Germany in bulk for distillation of the oil. Chamomile is used mainly as an anti-inflammatory and antiseptic, also antispasmodic and mildly sudorific. It is used internally mainly as a tisane for disturbances of the stomach associated with pain, for sluggish digestion, for diarrhea and nausea. More rarely and very effectively, it is used for inflammation of the urinary tract and for painful menstruation. Externally, the drug in powder form may be applied to wounds slow to heal, for skin eruptions, and infections, such as shingles and boils, also for hemorrhoids and for inflammation of the mouth, throat, and the eyes.

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.

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 Matricaria recutita Extract, just click the ADD TO CART button.

HBEL

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