OEL Fastrac Catalog

Drospirenone is an orally synthetic progestin medication for use by females of reproductive potential to prevent pregnancy. It can be used by itself or in birth control pills in combination with estrogen. In combination with ethinyl estradiol, it is indicated for conception control and for the treatment of moderate acne vulgaris in women who have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved menarche. In combination with ethinyl estradiol and levomefolate calcium, it is indicated for conception control, for the management of symptoms of premenstrual dysphoric disorder PMDD in women who choose to use oral contraceptive, for the treatment of moderate acne vulgaris in women who have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved menarche and for the improvement in folate status in women who choose to use oral contraception.

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 Drospirenone, just click the ADD TO CART button.

HBEL

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