Description

Propafenone Related Compound B ((2E)-1-[2-[(2Rs)-2-Hydroxy-3-(Propylamino)Propoxy]Phenyl]-3-Phenylprop-2-En-1-One) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the analysis of the antiarrhythmic drug Propafenone, ensuring product safety and regulatory compliance. It is an essential material for analytical laboratories, pharmaceutical manufacturers, and regulatory bodies focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Standard: Primary use as a certified reference material (CRM) for the identification and quantification of related substances in Propafenone API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Propafenone products meet stringent pharmacopoeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed to track the formation of degradation products in Propafenone under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research, metabolic pathway studies, and the development of impurity isolation and purification processes.

Basic Information

Product Name	Propafenone Related Compound B
CAS No.	88308-22-9
Molecular Formula	C21H25NO3
Molecular Weight	339.43 g/mol
Synonyms	(2E)-1-[2-[(2R)-2-Hydroxy-3-(propylamino)propoxy]phenyl]-3-phenylprop-2-en-1-one; (E)-1-[2-[(2R)-2-Hydroxy-3-(propylamino)propoxy]phenyl]-3-phenyl-2-propen-1-one; Propafenone Impurity B; Propafenone EP Impurity B; Propafenone Related Substance B; 1-[2-[(2R)-2-Hydroxy-3-(propylamino)propoxy]phenyl]-3-phenyl-2-propen-1-one; 2-Propen-1-one, 1-[2-[(2R)-2-hydroxy-3-(propylamino)propoxy]phenyl]-3-phenyl-, (2E)-
EINECS	Contact for details

Quality Control

Our Propafenone Related Compound B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (NMR, IR, MS), to ensure it meets the exacting standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.