Difluprednate

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6-Hydroxy Difluprednate

  • CAT NUMBER DCTI-C-2443
  • CAS NUMBER NA
  • MOLECULAR FORMULA C27H35FO8
  • MOLECULAR WEIGHT 506.57

Difluprednate 11-Keto Impurity

  • CAT NUMBER DCTI-C-2445
  • CAS NUMBER NA
  • MOLECULAR FORMULA C27H32F2O7
  • MOLECULAR WEIGHT 506.54

Difluprednate Aldehyde Impurity (Mixture of aldehy...

  • CAT NUMBER DCTI-C-2444
  • CAS NUMBER NA
  • MOLECULAR FORMULA C25H30F2O6 (aldehyde form); C25H32F2O7(hydrated form)
  • MOLECULAR WEIGHT 464.51 (aldehyde form); 482.52(aldehyde form)

Difluprednate Z-enol aldehyde impurity

  • CAT NUMBER DCTI-C-3207
  • CAS NUMBER NA
  • MOLECULAR FORMULA C21H24F2O4
  • MOLECULAR WEIGHT 378.42

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 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 C27H34F2O7, 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.

References
FAQ's

Frequently Asked Questions

Various analytical techniques, such as high-performance liquid chromatography (HPLC), liquid chromatography (LC), mass spectrometry (MS), etc., help in the analysis of Difluprednate impurities.

Controlling Difluprednate impurities ensures the drug's quality and safety. Impurity levels are minimized to acceptable limits by implementing suitable manufacturing processes and storage conditions.

Acetonitrile is a solvent used in analyzing many impurities in Difluprednate.

Difluprednate impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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