OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Carboxymethylcellulose sodium (CAS RN 9004-32-4/ 9085-26-1/ 74811- 65-7). Carboxymethylcellulose (CMC) is a cellulose derivative that consists of the cellulose backbone made up of glucopyranose monomers and their hydroxyl groups bound to carboxymethyl groups. It is added in food products as a viscosity modifier or thickener and emulsifier. It is also one of the most common viscous polymers used in artificial tears and has been shown to be effective in the treatment of aqueous tear-deficient dry eye symptoms and ocular surface staining. The viscous and mucoadhesive properties as well as its anionic charge allow prolonged retention time on the ocular surface. Sodium CMC is the most commonly used CMC salt. Sodium CMC has a variety of pharmaceutical uses as a tablet excipient, suspending and velocity increasing agent, bulk laxative, demulcent, dental adhesive, and as an absorption medium. Topically, sodium CMC is used as an ingredient of protective preparations for stoma care, in the management of wounds, and for mechanical protection of oral and perioral lesions, such as mouth ulceration. Sodium CMC is also indicated for use in artificial saliva preparations for dry mouth.

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 Carboxymethylcellulose sodium, just click the ADD TO CART button.

HBEL

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