Description

Propafenone Dimer Impurity-D10 is a deuterated, isotopically labeled impurity standard used in the analytical profiling of the antiarrhythmic drug Propafenone. This compound is essential for ensuring the accuracy and reliability of quantitative and qualitative analyses in pharmaceutical research and development. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals within the pharmaceutical and contract research organization (CRO) sectors for method development, validation, and compliance testing.

Application

• Primary use as a certified reference standard for the identification and quantification of dimeric impurities in Propafenone API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, LC-MS) to meet ICH Q3A/B guidelines for impurities.
• Used in pharmaceutical quality control (QC) and stability studies to monitor impurity profiles over time.
• Essential for regulatory submissions to agencies like the FDA and EMA, providing necessary data on specified impurities.
• Supports deuterium-labeled internal standard applications in mass spectrometry for improved analytical precision.
• Valuable for research and development into the degradation pathways and stability of Propafenone.

Basic Information

Product Name	Propafenone Dimer Impurity-D10
CAS No.	1346602-27-4
Molecular Formula	C32H34D10N2O4
Molecular Weight	Contact for details
Synonyms	1-[2-Hydroxy-3-(propylamino)propoxy]-3-(phenyl-D5)-2,3-bis(2-hydroxy-3-(propylamino)propoxy)phenylpropan-1-one-D5; Deuterated Propafenone Dimer; Propafenone Dimer-d10; Propafenone Dimer Impurity Standard-d10; 2'-(2-Hydroxy-3-(propylamino)propoxy)-3-phenyl-D5-propiophenone Dimer-d10; (RS)-Propafenone Dimer-d10; 1-[2-Hydroxy-3-(propyl-D7-amino)propoxy]-3-phenyl-2,3-bis(2-hydroxy-3-(propyl-D7-amino)propoxy)phenylpropan-1-one
EINECS	Contact for details

Quality Control

Every batch of Propafenone Dimer Impurity-D10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific purity, isotopic enrichment, and analytical results. We support compliance with ICH, USP, and EP guidelines for impurity standards.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
Purity (HPLC)	≥ 95.0%
Isotopic Enrichment	≥ 98.0 atom % D
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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