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 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.
- Ercoli, Alberto; Gardi, Rinaldo; Brianza, Carate, 17-Butyrate,21-Ester Derivatives Of 6alpha,9alpha-Difluoroprednisolone, Compositions And Use, Werner Lambert Co., US3780177A, December 18, 1973
- Zope, Murlidhar V.; Patel, Rahul M.; Patel, Ashwini Kumar; Patel, Samir G., Development and validation of a stability indicating RP-HPLC method for the determination of potential degradation products of Difluprednate in ophthalmic emulsion, International Journal of Pharmacy and Pharmaceutical Sciences, Volume: 10, Issue: 9, Pages: 79-86, 2018
Frequently Asked Questions
Difluprednate impurities can form during the synthesis due to incomplete reactions, contaminants in starting materials, or drug degradation under specific conditions such as exposure to light or moisture.
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).
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