Description

Desfluoro Ep Impurity D 5-Methoxy-1-[4-(Difluoromethyl)Phenyl]-1-Pentanone is a high-purity chemical reference standard and synthetic intermediate of significant importance in pharmaceutical development and quality control. This compound is critical for the accurate identification, quantification, and control of process-related impurities in active pharmaceutical ingredients (APIs), ensuring final drug product safety and regulatory compliance. It is primarily utilized by research institutions, analytical laboratories, and manufacturers within the global pharmaceutical and fine chemical sectors.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified external standard for HPLC, LC-MS, and GC-MS methods to quantify Desfluoro Ep Impurity D in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating analytical procedures in compliance with ICH Q2(R1) and Q3A/B guidelines.
• Process Chemistry Research: Used as a key intermediate or marker to study and optimize synthetic pathways, helping to minimize impurity formation during API manufacturing.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing and stability studies to monitor impurity profiles and ensure product consistency.
• Regulatory Submissions: Provides necessary data and characterization for impurity identification reports required by regulatory bodies like the FDA and EMA.
• Academic & Contract Research: Supports investigative research in organic synthesis, medicinal chemistry, and impurity fate and tolerance studies.

Basic Information

Product Name	Desfluoro Ep Impurity D 5-Methoxy-1-[4-(Difluoromethyl)Phenyl]-1-Pentanone
CAS No.	1391053-78-3
Molecular Formula	C14H18F2O2
Molecular Weight	256.29 g/mol
Synonyms	Desfluoro Eplerenone Impurity D; 5-Methoxy-1-[4-(difluoromethyl)phenyl]pentan-1-one; 1-Pentanone, 5-methoxy-1-[4-(difluoromethyl)phenyl]-; Eplerenone Desfluoro Impurity D; Eplerenone Related Compound D (Desfluoro); 4-(Difluoromethyl)phenyl 5-methoxypentyl ketone
EINECS	Contact for details

Quality Control

Every batch of Desfluoro Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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