OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to hyoscyamine sulfate (CAS RN 620-61-1; 2472-17-5; 55-48-1), hyoscyamine hydrobromide (CAS RN 306-03-6), hyoscyamine sulfate hydrate (CAS RN 5908-99-6), hyoscyamine hydrochloride (CAS RN 33952-38-4; 5934-50-9), hyoscyamine tartrate (CAS RN 7459-98-5), and hyoscyamine borate (CAS RN 51460-78-7). Hyoscyamine is used to control symptoms associated with disorders of the gastrointestinal (GI) tract. It is indicated for use in the treatment of bladder spasms, peptic ulcer disease, diverticulitis, colic, irritable bowel syndrome, cystitis, and pancreatitis. Hyoscyamine can also be used to treat certain heart conditions, to control the symptoms of Parkinson’s disease, rhinitis, and to reduce excess saliva production. Hyoscyamine is an isomer of atropine and is also known as levo-atropine. It exhibits anticholinergic activity and functions as a non-selective, competitive antagonist of muscarinic receptors, inhibiting the parasympathetic activities of acetylcholine on the salivary, bronchial, and sweat glands as well as in the eye, heart, and GI tract. The actions of hyoscyamine result in a reduction in salivary, bronchial, gastric, and sweat gland secretions, mydriasis, cycloplegia, change in heart rate, contraction of the bladder detrusor and GI smooth muscles, and decreased GI motility.

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 Hyoscyamine, just click the ADD TO CART button.

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