OEL Fastrac Catalog

Somatostatin, also known as growth hormone-inhibiting hormone, is a naturally occurring peptide hormone of 14 or 28 amino acid residues that regulates the endocrine system. A synthetic cyclic 14-amino acid peptide, which is identical in structure and action to natural somatostatin, is available. Antineoplastic effects and potential uses of somatostatin on various tumors, including pituitary adenomas, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), paragangliomas, carcinoids, breast cancers, malignant lymphoma, and small-cell lung cancers, have been extensively investigated. Somatostatin has been used in the clinical setting for the diagnosis of acromegaly and gastrointestinal (GI) tract tumors. Its analogs have been developed to achieve more favorable kinetics for efficient use in the management of acute conditions, such as esophageal varices. Somatostatin is approved in India and other countries for the treatments of acute, severe GI hemorrhage, resulting from gastric or duodenal ulcers, hemorrhagic gastritis and esophageal varices, for the treatment of intestinal, biliary and pancreatic fistulae, for symptomatic treatment of excessive secretion from endocrine tumors of the GI tract, for treatment of postoperative complications and as prophylaxis following pancreatic surgery and coadjuvant treatment in diabetic ketoacidosis.

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 Somatostatin, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.