OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Sodium orthosilicate (CAS RN 13472-30-5). Orthosilicic acid (OSA), also known as “silicic acid (H4SiO4)”, is the natural form of silicon (Si) formed by the hydration of silicon dioxide (SiO2). Dietary silicon deficiency can be overcome by the consumption of high-bioavailability Si-rich foods and the use of Si supplements. A good form of supplementation is OSA, usually stabilized by the introduction of a methyl group such as choline (ch-OSA) or vanillin (vc-OSA). Orthosilicic acid (OSA) is naturally found in diatomaceous earth in the form of amorphous silica and extracts from Si-rich plants, such as horsetail (Eguiseti herba Linnée) and nettles (Urtica dioica L.). Silicon (Si) is a microelement that performs a number of important functions in the human body, being involved in the formation and maintenance of normal osteocartilaginous connective tissue, such as skin, hair, and nails, and having beneficial effects in the prevention of cardiovascular and neurodegenerative diseases.

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 Orthosilicic Acid, just click the ADD TO CART button.

HBEL

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