General Information

Difluprednate Impurities and Difluprednate

Daicel Pharma synthesizes high-quality impurities for Difluprednate, an active pharmaceutical ingredient. These impurities, including 6-Hydroxy Difluprednate, Difluprednate 11-Keto Impurity, and Difluprednate Aldehyde Impurity (Mixture of aldehyde and the hydrated form), play a vital role in assessing the purity, reliability, and safety of Difluprednate. Daicel Pharma also offers a customized synthesis of Difluprednate impurities to cater to client requirements, with worldwide delivery options available.

Difluprednate [CAS: 23674-86-4], a derivative of prednisolone acetate, is a potent topical corticosteroid having anti-inflammatory properties. It controls inflammation in the eye’s anterior segment and reduces cystoid macular edema (CME) in pediatric patients with uveitis when used alongside systemic immunomodulatory therapy. Furthermore, Difluprednate manages inflammation and pain related to ocular surgery.

Difluprednate: Use and Commercial Availability  

Difluprednate is a topical corticosteroid for managing inflammation and pain linked to ocular surgery. It is known as DFBA or difluoroprednisolone butyrate acetate, a butyrate ester derived from 6(α), 9(α)-difluoro prednisolone acetate. It treats endogenous anterior uveitis. Difluprednate is available under the brand name Durezol.

Difluprednate Structure and Mechanism of Action

The chemical name of Difluprednate is (6α,11β)-21-(Acetyloxy)-6,9-difluoro-11-hydroxy-17-(1-oxobutoxy)pregna-1,4-diene-3,20-dione. Its chemical formula is C₂₇H₃₄F₂O_7, and its molecular weight is approximately 508.5 g/mol.

Difluprednate binds and activates the glucocorticoid receptor (GR). It inhibits the synthesis of arachidonic acid and prevents the formation of inflammatory mediators like prostaglandins.

Difluprednate Impurities and Synthesis

Difluprednate impurities can arise during the synthesis¹ or storage of the drug. They may impact the quality, efficacy, and safety of Difluprednate. They can affect the drug’s stability, bioavailability, and potential adverse effects. Therefore, comprehensive analysis and control of Difluprednate impurities are necessary to comply with regulatory guidelines and ensure patient safety. It involves thorough characterization, quantification, and implementation of measures to minimize impurity formation during manufacturing and storage processes.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Difluprednate impurity standards, including 6-Hydroxy Difluprednate, Difluprednate 11-Keto Impurity, and Difluprednate Aldehyde Impurity (Mixture of aldehyde and the hydrated form). They generate from an analytical facility that complies with cGMP standards. The CoA provides a detailed characterization report with data obtained through techniques such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². We give additional data like 13C-DEPT upon request. Daicel Pharma synthesizes unknown Difluprednate impurities or degradation products. Every delivery accompanies a complete characterization report.