OEL Fastrac Catalog

Sodium sulfoxylate formaldehyde (also known as rongalite) is the sodium salt form of formaldehydesulfoxylate, also known as hydroxymethanesulfinic acid. It was originally developed as a treatment for mercury poisoning but was found to be of limited value. Currently, it is widely used in organic synthesis. It can be used as a reducing agent for elemental selenium and tellurium, diselenides, α‐halo ketones, and aromatic aldehydes. It yields symmetrical sulfones with primary halides and with Michael acceptors. Sodium sulfoxylate formaldehyde is a water-soluble antioxidant and is generally used as the dihydrate. It is used as an excipient in the formulation of injection products at a level of up to 0.1% w/v (weight by volume) in the final preparation administered to the patient.

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 Formaldehydesulfoxylate, just click the ADD TO CART button.

HBEL

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