OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Pyridoxine hydrochloride (CAS RN 58-56-0), Pyridoxine 5’-phosphate (CAS RN 447-05-2), Pyridoxal (CAS RN 66-72-8), Pyridoxal hydrochloride (CAS RN 65-22-5), Pyridoxal phosphate (CAS RN 54-47-7), Pyridoxal 5’-phosphate monohydrate (CAS RN 41468-25-1), Pyridoxamine (CAS RN 85-87-0), Pyridoxamine dihydrochloride (CAS RN 524-36-7), Pyridoxamine hydrochloride (CAS RN 5103-96-8), Pyridoxamine 5’-phosphate (CAS RN 529-96-4), and Pyridoxamine phosphate hydrochloride (CAS RN 951-83-7). Pyridoxine is the 4-methanol form of vitamin B6, an important water-soluble vitamin that is naturally present in many foods. As its classification as a vitamin implies, vitamin B6 (and pyridoxine) are essential nutrients required for normal functioning of many biological systems within the body. While many plants and microorganisms are able to synthesize pyridoxine through endogenous biological processes, animals must obtain it through their diet. Pyridoxine is indicated for the treatment of vitamin B6 deficiency and for the prophylaxis of isoniazid-induced peripheral neuropathy. It is also approved by Health Canada for the treatment of nausea and vomiting in pregnancy in a combination product with doxylamine.

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 Pyridoxine, just click the ADD TO CART button.

HBEL

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