Description

4-Hydroxy Propafenone Hydrochloride is a key pharmaceutical intermediate and reference standard of significant commercial and research importance. Its primary value lies in its critical role in the synthesis and quality control of the antiarrhythmic drug Propafenone, ensuring batch-to-batch consistency and regulatory compliance. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on cardiovascular drug development and production.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of the active pharmaceutical ingredient (API) Propafenone Hydrochloride.
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing of Propafenone API and finished dosage forms.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research as a known metabolite of Propafenone.
• Impurity Standard: Serves as a certified reference material for identifying and quantifying related substances in Propafenone drug products.
• Research & Development: Utilized in medicinal chemistry for the development of new antiarrhythmic agents and structural analogs.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing a qualified standard for impurity profiling and stability studies.

Basic Information

Product Name	4-Hydroxy Propafenone Hydrochloride
CAS No.	86383-31-5
Molecular Formula	C21H28ClNO3
Molecular Weight	377.91 g/mol
Synonyms	1-[2-Hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone Hydrochloride; 4'-Hydroxypropafenone Hydrochloride; Propafenone Hydrochloride Impurity C (EP); Propafenone Related Compound C; 4-OH Propafenone HCl; 4-Hydroxypropafenone HCl; 5-Hydroxy Propafenone Hydrochloride (common alternate numbering); 1-[2-Hydroxy-3-(propylamino)propoxy]-3-phenyl-1-propanone Hydrochloride
EINECS	Contact for details

Quality Control

Our 4-Hydroxy Propafenone Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets stringent specifications suitable for pharmaceutical R&D and manufacturing. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.