OEL Fastrac Catalog

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.

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 Manganese, just click the ADD TO CART button.

HBEL

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