Description

Difluprednate Impurity 11 is a designated impurity of the synthetic corticosteroid Difluprednate, a critical reference standard for analytical and regulatory purposes. This compound is essential for pharmaceutical research and development, specifically for method validation, stability studies, and ensuring the purity and safety of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Difluprednate Impurity 11 in API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Stability Indicating Method: Employed in forced degradation and long-term stability studies to track impurity formation and ensure product shelf-life.
• Quality Control & Batch Release: Serves as a system suitability standard and for setting specification limits in routine QC testing of Difluprednate API.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Difluprednate under various stress conditions.

Basic Information

Product Name	Difluprednate Impurity 11
CAS No.	1270039-29-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6α,9-Difluoro-11β,17,21-trihydroxy-16-methylenepregna-1,4-diene-3,20-dione 21-acetate 17-butyrate Impurity 11; Difluprednate Related Compound 11; (6α,11β,16α)-6,9-Difluoro-11,17,21-trihydroxy-16-methylenepregna-1,4-diene-3,20-dione 21-acetate 17-butyrate Impurity; Impurity 11 of Difluprednate; Difluprednate EP Impurity J; Difluprednate USP Impurity 11
EINECS	Contact for details

Quality Control

Our Difluprednate Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.