Please note, this OEL/ADE monograph also applies to promethazine hydrochloride (CAS RN 58-33-3), Promethazine maleate (CAS RN 5992-13-2; 27059-74-1), Promethazine theoclate (CAS RN 7009-67-8), Promethazine hydrobromide (CAS RN 5568-88-7), Promethazine pamoate (CAS RN N.A.), Promethazine oxalic acid (CAS RN N.A.), Promethazine hydrochloride adipic acid (CAS RN N.A.), Promethazine hydrochloride fumaric acid (CAS RN N.A.), and Promethazine hydrochloride succinic acid (CAS RN N.A.). Promethazine hydrochloride is a phenothiazine derivative which possesses antihistaminic, sedative, anti-motion-sickness, antiemetic, and anticholinergic effects. It is indicated for the following conditions; perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis due to inhalant allergens and foods, mild/uncomplicated allergic skin manifestations of urticaria and angioedema, amelioration of allergic reactions to blood or plasma, dermographism, anaphylactic reactions (as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled), preoperative, postoperative, or obstetric sedation, prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, adjunctive therapy to meperidine or other analgesics for control of postoperative pain, sedation in both children and adults as well as for the relief of apprehension and production of light sleep from which the patient can be easily aroused, active and prophylactic treatment of motion sickness, and as an antiemetic therapy in postoperative patients.

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.


CAS Registry Number:
Brand names:
Pentazine, Phenadoz, Phenergan, Phenergan Fortis, Promacot
$679 USD


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 Promethazine, just click the ADD TO CART button.


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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing