Description

Propafenone Impurity H (Ep/Bp/Usp) is a high-purity reference standard used in the analytical profiling and quality control of the antiarrhythmic drug Propafenone. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and routine batch testing in the pharmaceutical industry. The CAS number for this compound is 27439-12-9.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Propafenone Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Batch Release: Used in-house by QC laboratories to monitor impurity levels against specified limits as per EP, BP, USP, or ICH Q3A/B thresholds.
• Regulatory Submissions & Compliance: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A.
• Pharmacopoeial Testing: Direct application in conducting official monographic tests as specified in the European Pharmacopoeia (EP), British Pharmacopoeia (BP), and United States Pharmacopeia (USP).

Basic Information

Product Name	Propafenone Impurity H (Ep/Bp/Usp)
CAS No.	27439-12-9
Molecular Formula	C22H29NO3
Molecular Weight	355.47 g/mol
Synonyms	1-[2-Hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone; Propafenone Related Compound H; Propafenone EP Impurity H; Propafenone BP Impurity H; Propafenone USP Impurity H; 3-Phenyl-1-[2-hydroxy-3-(propylamino)propoxy]propiophenone; N-Propyl-2-hydroxy-3-(3-phenylpropionylphenoxy)propylamine
EINECS	Contact for details

Quality Control

Every batch of Propafenone Impurity H (Ep/Bp/Usp) is manufactured and analyzed under strict quality systems. The product is characterized and qualified against pharmacopoeial standards (EP/BP/USP) using advanced techniques including HPLC, GC-MS, and NMR to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, assay, and impurity profile. Our quality commitment supports GMP/GLP compliance for critical pharmaceutical applications.

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); ensure the container is sealed tightly after each use to prevent degradation due to 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%
Purity (HPLC)	≥ 98.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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