Please note, this OEL/ADE monograph also applies to Manganese oxide (CAS RN 1344-43-0), Manganese sulfate anhydrous (CAS RN 7785-87-7), Manganese sulfate monohydrate (CAS RN 10034-96-5), Manganese chloride (CAS RN 11132-78-8), Manganese chloride tetrahydrate (CAS RN 13446-34-9), and Manganese gluconate (CAS RN 6485-39-8). Manganese (Mn) is an essential trace element that is naturally present in many foods and is available as a dietary supplement. The human body contains about 10 mg to 20 mg Mn, of which 25% to 40% is in bone. The liver, pancreas, kidney, and brain also contain Mn. Manganese (Mn) is a transition metal used for supplementation of Mn during Total Parenteral Nutrition (TPN). Administration of Mn supplementation helps to maintain plasma levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. Manganese is a naturally occurring metal that is found in many types of rocks. Pure Mn is silver-colored, but does not occur naturally. It combines with other substances such as oxygen, sulfur, or chlorine. Manganese can also be combined with carbon to make organic Mn compounds. Common organic Mn compounds include pesticides, such as maneb or mancozeb, and methylcyclopentadienyl manganese tricarbonyl (MMT), a fuel additive in some gasolines.
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.
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:
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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.