OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Alendronic acid monohydrate (CAS RN 138624-11-0), Alendronate sodium anhydrous (CAS RN 129318-43-0), alendronate sodium trihydrate (CAS RN 121268-17-5) Alendronate disodium (CAS RN 134606-40-9), Alendronate sodium monohydrate (CAS RN 260055-05-8), and Alendronate calcium (CAS RN 137504-90-6). In addition, this monograph contains the pediatric ADE (pADE). Alendronic acid, also known as alendronate, is indicated to treat various forms of osteoporosis and Paget’s disease. Alendronic acid is a bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. At the cellular level, it shows localization to sites of bone resorption and inhibits osteoclast resorption and activity. Alendronic acid does not interfere with osteoclast recruitment to attachment.

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 Alendronic acid, just click the ADD TO CART button.

HBEL

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