Description

Propafenone Ep Impurity D is a specified impurity and degradation product of the antiarrhythmic drug Propafenone. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry to ensure the purity, safety, and efficacy of Propafenone drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Propafenone API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and that impurity levels remain within specified safety thresholds.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Propafenone Ep Impurity D
CAS No.	91401-73-9
Molecular Formula	C22H29NO4
Molecular Weight	371.47 g/mol
Synonyms	1-[2-Hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone; Propafenone Impurity D; Propafenone Related Compound D; Propafenone EP Impurity D; 2'-Hydroxy-3'-(propylamino)propoxy-3-phenylpropiophenone; Propafenone Hydrochloride Impurity D; Benzeneacetamide, N-(2-hydroxy-3-phenoxypropyl)-N-propyl-α-phenyl-
EINECS	Contact for details

Quality Control

Every batch of Propafenone Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC and GC to ensure compliance with Pharmacopoeial standards (EP/ USP) and ICH guidelines. 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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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