OEL Fastrac Catalog

Methylene blue (also known as methylthioninium chloride) is a compound consisting of dark green crystals or crystalline powder, having a bronze-like luster. Solutions in water or alcohol have a deep blue color. Methylene blue is commonly used dye that also exhibits antioxidant, antimalarial, antidepressant and cardioprotective properties. The intravenous (IV) form of methylene blue is approved by the United States (US) Food and Drug Administration (FDA) for the treatment of pediatric patients and adult patients with acquired methemoglobinemia. Historically, it had been widely used in Africa to treat malaria, but it disappeared when chloroquine and other drugs entered the market. Its use as a urinary tract antiseptic has also been investigated. Methylene blue is also an investigational drug that has been shown in early clinical trials to be an inhibitor of tau protein aggregation and, therefore, the drug is of potential interest for the treatment of patients with Alzheimer's disease. Finally, methylene blue has been investigated for the treatment of ifosfamide-induced encephalopathy.

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 Methylene Blue, just click the ADD TO CART button.

HBEL

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