OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to minocycline hydrochloride (CAS RN 13614-98-7), Minocycline disulfate (CAS RN Not available), and Minocycline hydrochloride dihydrate (CAS RN 128420-71-3). Minocycline is a second-generation tetracycline antibiotic that is active against gramnegative and gram-positive bacteria. Oral and topical minocycline are indicated to treat inflammatory lesions of acne vulgaris. Subgingival microspheres are indicated as an adjunct treatment in the reduction of pocket depth in adults with periodontitis. Oral and intravenous (IV) formulations are indicated to treat infections of susceptible microorganisms. These include Rickettsia, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydophila psittaci, Ureaplasma urealyticum, Borrelia recurrentis, Haemophilus ducreyi, Yersinia pestis, Francisella tularensis, Vibrio cholerae, Campylobacter fetus, Brucella species, Bartonella bacilliformis, Klebsiella granulomatis, Escherichia coli, Enterobacter aerogenes, Shigella species, Acinetobacter species, Haemophilus influenzae, and Klebsiella species. Additionally, oral minocycline is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Minocycline is available in tablets, film-coated tablets, extended-release tablets, and capsules for oral administration. It is also available as solution for IV injection, as controlled-released microspheres for subgingival administration, as ointment for periodontal administration, and as topical formulations.

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 Minocycline, just click the ADD TO CART button.

HBEL

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