Description

Propafenone Ep Impurity F is a designated impurity standard used in the analytical profiling of the antiarrhythmic drug Propafenone. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments for method validation, stability studies, and compliance with pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Propafenone Ep Impurity F in Propafenone hydrochloride API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating robust analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, to monitor impurity profiles.
• Stability Indicating Method: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Quality Control and Batch Release: Serves as a system suitability standard in routine QC testing to ensure each batch of Propafenone API meets stringent impurity limits.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Pharmacopeial Compliance: Aids in compliance testing against monographs in the European Pharmacopoeia (EP) and United States Pharmacopeia (USP) which specify limits for known and unknown impurities.

Basic Information

Product Name	Propafenone Ep Impurity F
CAS No.	1329643-40-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Propafenone Related Compound F; Propafenone EP Impurity F; Propafenone Impurity F; 1-[2-Hydroxy-3-(propylamino)propoxy]-3-phenylpropan-2-one; A potential process-related impurity of Propafenone.
EINECS	Contact for details

Quality Control

Every batch of Propafenone Ep Impurity F is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The container should be kept securely sealed to protect the integrity of the standard from moisture and atmospheric contaminants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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