OEL Fastrac Catalog

Carmoisine, also known as Azorubine or E122, is a red azo dye that consists essentially in the form of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo)-1-naphthalenesulfonate (2). In the United States, this coloring agent was listed in 1939 as D&C Red No. 10 for use in externally applied drugs and cosmetics. It was delisted in 1963 and was never used in foods in the US. In the EU, carmoisine is known as E number E122 and is authorized for use in certain foods and beverages, such as cheeses, dried fruit, and some alcoholic beverages. It is also permitted for its use in cats and dogs as colorant additives. Carmoisine is also permitted for use as an excipient in medications. In Canada, carmoisine is approved as a color additive.

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 Carmoisine, just click the ADD TO CART button.

HBEL

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