Description

Difluprednate Impurity 17 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Difluprednate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of a specific impurity in Difluprednate API batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating stability-indicating assay methods for Difluprednate.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency in pharmaceutical production.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Difluprednate formulations.
• Research & Development: Used in R&D laboratories for studying the degradation pathways and metabolism of Difluprednate.

Basic Information

Product Name	Difluprednate Impurity 17
CAS No.	1296262-60-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Difluprednate Related Compound 17; Difluprednate EP Impurity 17; Difluprednate USP Impurity 17; 6α,9-Difluoro-11β,17,21-trihydroxy-16-methylenepregna-1,4-diene-3,20-dione Impurity; 1296262-60-6; DFL Impurity 17
EINECS	Contact for details

Quality Control

Every batch of Difluprednate Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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