Description

Difluprednate Impurity 15 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Difluprednate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and regulatory compliance of Difluprednate-based drug products. It serves as an essential reference material for method development, validation, and routine batch testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Difluprednate API and finished drug products.
• Analytical Method Development: Critical for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and finished dosage formulators to set and meet stringent impurity specification limits as per ICH guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) during drug product shelf-life studies.
• Research & Development: Used in pharmaceutical R&D to understand the degradation pathways and chemistry of Difluprednate.

Basic Information

Product Name	Difluprednate Impurity 15
CAS No.	2285-44-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Difluprednate Related Compound 15; Difluprednate EP Impurity C; Difluprednate USP Impurity; 6α,9-Difluoro-11β,17,21-trihydroxy-16-methylenepregna-1,4-diene-3,20-dione 21-acetate 17-butyrate Impurity; 21-Acetoxy-6α,9-difluoro-11β-hydroxy-16-methylenepregna-1,4-diene-3,20-dione 17-butyrate Impurity; Prednisolone Derivative Impurity; Steroidal Impurity
EINECS	Contact for details

Quality Control

Every batch of Difluprednate Impurity 15 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake.

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)	Report individual and total impurities
Assay (HPLC)	90.0% - 110.0% on as-is basis
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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