OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to glucosamine hydrochloride (CAS RN 66-84-2), glucosamine sulfate (CAS RN 29031-19-4), glucosamine sulfate potassium chloride (CAS RN 1296149-08-0), Sodium N-sulfoglucosamine (CAS RN 38899-05-7), and acetylglucosamine (CAS RN 7512-17-6). Glucosamine hydrochloride is marketed as a supplement that is indicated for the support of the structure and function of joints, usually in the treatment of osteoarthritis. Since glucosamine is a precursor for the creation of glycosaminoglycans, and glycosaminoglycans are a major component of joint cartilage and forming cartilage tissue in the body, supplemental glucosamine may help to rebuild cartilage and treat arthritis; glucosamine is also present in tendons and ligaments. Glucosamine must be synthesized by the body, but the ability to do this declines with age; therefore, glucosamine and its salts have been advocated in the treatment of rheumatic disorders including osteoarthritis.

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.

How to order

To order an OEL/ADE monograph for Glucosamine, just click the ADD TO CART button.

HBEL

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