OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to pilocarpine hydrochloride (CAS RN 54-71-7), pilocarpine borate (CAS RN 16509-56-1), and pilocarpine nitrate (CAS RN 148-72-1). PPilocarpine is a natural alkaloid extracted from plants of the genus Pilocarpus with cholinergic agonist activity (1). Pilocarpine is a muscarinic agonist used mainly in the treatment of glaucoma and the treatment of dry eye or dry mouth. It is also indicated for the treatment of radiation-induced dry mouth (xerostomia) and symptoms of dry mouth in patients with Sjogren’s syndrome. It is also used as an ophthalmic solution in the treatment of presbyopia, elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, management of acute angle-closure glaucoma, prevention of postoperative elevated IOP associated with laser surgery, and induction of miosis (pupil constriction). It has been used as a diaphoretic in diagnostic tests for cystic fibrosis and leprosy.

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 Pilocarpine, just click the ADD TO CART button.

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