Description

Propafenone Impurity G is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiarrhythmic drug Propafenone by serving as a key marker for impurity profiling and control. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory bodies focused on method development and validation. The compound is supplied with comprehensive analytical data to support compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control and release testing of Propafenone API and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify Propafenone Impurity G in drug substances and products.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing a characterized impurity for identification and qualification reports.
• Pharmacopeial Testing: Employed to verify compendial procedures as per USP, EP, or other international pharmacopeia standards for Propafenone.
• Research & Synthesis: Serves as a building block or intermediate in chemical research aimed at understanding Propafenone metabolism or synthesizing related analogs.

Basic Information

Product Name	Propafenone Impurity G
CAS No.	1346603-80-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Propafenone Related Compound G; Propafenone EP Impurity G; Propafenone USP Impurity G; 1-[2-Hydroxy-3-(propylamino)propoxy]-3-phenylpropan-1-one; Propafenone Hydrochloride Impurity G; Propafenone Degradation Product G
EINECS	Contact for details

Quality Control

Every batch of Propafenone Impurity G is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials qualified against USP and EP reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

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