OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to chlorhexidine acetate (CAS RN 56-95-1), chlorhexidine gluconate/chlorhexidine digluconate (CAS RN 18472-51-0/82432-16-4), chlorhexidine hydrochloride (CAS RN 3697-42-5), chlorhexidine phosphanilate (CAS RN 77146-42-0), chlorhexidine dodecanoate (CAS RN N/A), chlorhexidine diacetate monohydrate (CAS RN 206986-79-0), and chlorhexidine hexahydrate (CAS RN N/A). Chlorhexidine is an antimicrobial agent indicated for the use in skin cleansing procedures, oral rinsing, and to treat gum conditions. Chlorhexidine is an antiseptic antimicrobial with bactericidal activity that is used as a topical skin cleanser or as a dental mouth rinse to reduce plaque. The drug is a base and is stable as a salt, the most commonly studied being chlorhexidine gluconate. At physiologic pH, chlorhexidine salts dissociate releasing a positively charged component. The bactericidal effect of chlorhexidine is a result of the binding of this cationic molecule to negatively charged bacterial cell walls and extramicrobial complexes. At low concentrations, this causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorous resulting in a bacteriostatic effect. At high concentrations of chlorhexidine, the cytoplasmic contents of the bacterial cell precipitate and result in cell death.

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 Chlorhexidine, just click the ADD TO CART button.

HBEL

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