Risedronate Acid

Please note, this OEL/ADE monograph also applies to risedronate sodium (CAS RN 115436-72-1). Risedronate is indicated to treat various forms of osteoporosis and Paget’s disease. Risedronate binds to bone hydroxyapatite, and at the cellular level, inhibits osteoclast activity, thereby modulating bone metabolism. Although the osteoclasts adhere normally to the bone surface, they show evidence of reduced active resorption by the lack of ruffled border. Risedronate is an antiresorptive agent. It has an affinity for hydroxyapatite and acts by inhibiting osteoclast-mediated bone resorption. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Animal studies showed that risedronate treatment reduces bone turnover (activation frequency or the rate at which bone remodeling sites are activated) and decreases bone resorption at remodeling sites.

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.

Risedronate Acid

CAS Registry Number:
105462-24-6
Trade names:
Actonel®, Atelvia®
Cost:
$639 USD

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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), 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. 10-12 pages in length, with calculations and cited references.
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To order an OEL/ADE monograph for Risedronate Acid, just click the ADD TO CART button.

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  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories