OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Sucrose octasulfate (CAS RN 57680-56- 5). Sucrose is a glycosyl glycoside formed by glucose and fructose units joined by an acetal oxygen bridge from the hemiacetal of glucose to the hemiketal of the fructose. It has a role as an osmolyte, a sweetening agent, a human metabolite, an algal metabolite, a Saccharomyces cerevisiae metabolite, an Escherichia coli metabolite and a mouse metabolite. Sucrose is a normal component of the human diet. It is the starting material in the fermentative production of ethanol, butanol, glycerol, and alcoholic beverages. It is used in the pharmaceutical industry as a preservative, in the plastics and cellulose industry, and in the manufacture of ink and transparent soaps. The monosaccharides, disaccharides, and related ingredients have a number of reported functions in cosmetics, with the most common use as a skin-conditioning agent. Other commonly reported functions are as a humectant or as a flavoring agent.

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 Sucrose, just click the ADD TO CART button.

HBEL

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