OEL Fastrac Catalog

Red vine leaf extract is a substance of unknown or variable composition, complex reaction products, or biological materials (UVCB) and consists of the dried leaves of the black to pulpred grape (Vitis viniferae folium). Polyphenols are typical components of grapes and belong to the most complex substance groups occurring in plants. In red vine leaves (Vitis vinifera), more than 100 different compounds are found. Most of these substances belong to one of the four main groups, either the flavonoids (such as flavonols), the anthocyanins, the procyanidins, or the phenol-carbonic acids. According to the French Pharmacopoeia, the dried leaves of grapevine contain at least 4% of total polyphenols and 0.2% of anthocyanins. Vine leaves contain a wide range of polyphenol flavonoids (up to 3.5%) including flavon(ol)- glycosides and glucuronides, quercetin-3-O-beta-D-glucuronide (most abundant of flavonoids), isoquercitrin, anthocyanins, oligomeric proanthocyanidins, catechin, epicatechin monomers and dimmers, and gallic acid. The phytoalexin trans-resveratrol, another polyphenolic substance belonging to the stilbene group, can also be found in grapevine. In vine leaves, organic acids such as malic acid, oxalic acid, and tartaric acid are also seen. Citric, fumaric, and succinic acid can be detected in the leaves only in traces. Compared to the grape berries, grape leaves are richer in the content of carotenoids and vitamin C (2). Compared to the marc of the grapes, vine leaves contain more than 20-fold the concentration of vasoactive polyphenols

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.

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HBEL

If you're wondering about HBEL, we have something for you.