Description

Difluprednate Impurity 14 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the corticosteroid Difluprednate by enabling accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology sectors who require reliable reference standards for method validation and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of a specific impurity in Difluprednate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure drug product consistency meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate control of the manufacturing process.
• Stability Studies: Used as a marker to track the formation of degradation products in Difluprednate formulations under various stress conditions.
• Research and Development: Supports synthetic chemistry research for process optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Difluprednate Impurity 14
CAS No.	1234557-20-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Difluprednate Related Compound 14; Difluprednate EP Impurity D; Difluprednate USP Impurity; (6α,11β)-21-(Acetyloxy)-6,9-difluoro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione Impurity; 21-Acetate-6,9-difluoro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione Impurity 14; Durezol Impurity; 6α,9α-Difluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-acetate Impurity
EINECS	Contact for details

Quality Control

Every batch of Difluprednate Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results from tests including HPLC purity, related substances, and spectroscopic identification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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