OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Histamine hydrochloride (CAS RN 55-36-7), Histamine dihydrochloride (CAS RN 56-92-8), Histamine phosphate (CAS RN 51-74-1), and Histamine bisphosphate monohydrate (CAS RN 23297-93-0). Histamine is a member of the class of imidazoles. It is a depressor amine derived by enzymatic decarboxylation of histidine. It is a powerful stimulant of gastric secretion, a constrictor of bronchial smooth muscle, a vasodilator, and also a centrally acting neurotransmitter. Histamine phosphate is indicated as a diagnostic aid for the evaluation of gastric acid secretory function, for asthma diagnosis, and as positive skin test control in evaluation of immediate hypersensitivity testing. Histamine dihydrochloride is used in combination with interleukin (IL)-2 (an oncologic medicine) as maintenance treatment in adults with acute myeloid leukemia (AML), a type of cancer affecting the white disease after the first course of treatment). Histamine is also an ingredient of topical drugs for the relief of joint pain or muscle aches and pains.

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 Histamine, just click the ADD TO CART button.

HBEL

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