Carboxymethylcellulose Sodium

Please note, this OEL/ADE monograph also applies to carboxymethylcellulose (CAS RN 9000-11-7). Carboxymethylcellulose (CMC) sodium, also known as cellulose gum or sodium CMC, is a cellulose derivative with carboxymethyl groups (-CH2-COOH) bound to some of the hydroxyl groups of the glucopyranose monomers. It 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; it is also used as an emulsifier or stabilizer in the food industry. 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 and for use in the symptomatic relief of dry eye.

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.

Carboxymethylcellulose Sodium

CAS Registry Number:
9004-32-4
Trade names:
Celluvisc®, Refresh® Tears, Refresh®
Cost:
$639 USD

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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), 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

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To order an OEL monograph for this compound, just click the ADD TO CART button.

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  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories