Description

Difluprednate Impurity 6 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: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Difluprednate drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies of Difluprednate formulations to track impurity formation over time.
• Research & Development: Used in academic and industrial R&D for studying the degradation pathways and metabolism of Difluprednate.

Basic Information

Item	Details
Product Name	Difluprednate Impurity 6
CAS No.	167997-12-8
Molecular Formula	C27H34F2O7
Molecular Weight	508.55 g/mol
Synonyms	6β,9-Difluoro-11β,17,21-trihydroxy-16-methylenepregna-1,4-diene-3,20-dione 21-acetate 17-butyrate; Difluprednate Related Compound 6; Difluprednate EP Impurity B; Difluprednate USP Impurity; (6β,11β,16α)-6,9-Difluoro-11,17,21-trihydroxy-16-methylenepregna-1,4-diene-3,20-dione 21-acetate 17-butyrate
EINECS	Contact for details

Quality Control

Our Difluprednate Impurity 6 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with ICH Q3A/B guidelines and relevant pharmacopoeial standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 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.