Description

Propafenone Impurity 23 (Propafenone β-D-Glucuronide) is a key glucuronide metabolite impurity of the antiarrhythmic drug Propafenone, identified by CAS NO 91411-76-6. This reference standard is critical for pharmaceutical research and development, specifically for method development, validation, and ensuring the purity and safety of the active pharmaceutical ingredient (API). It is an essential analytical tool for quality control laboratories and regulatory affairs departments within the pharmaceutical industry to meet stringent pharmacopeial standards for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Propafenone-related impurities in API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS/MS methods to separate and accurately measure this specific glucuronide metabolite.
• Pharmacokinetic and Metabolism Studies: Used in research to understand the metabolic pathways, bioavailability, and clearance mechanisms of Propafenone.
• Quality Control & Assurance (QC/QA): Ensures batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities in new drug substances and products.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug approval dossiers.
• Stability Studies: Monitors the formation of this degradation product in Propafenone formulations under various stress conditions.

Basic Information

Product Name	Propafenone Impurity 23 (Propafenone β-D-Glucuronide)
CAS No.	91411-76-6
Molecular Formula	C28H35NO10
Molecular Weight	545.58 g/mol
Synonyms	Propafenone Glucuronide; Propafenone β-D-Glucopyranosiduronic Acid; 1-[2-[2-Hydroxy-3-(propylamino)propoxy]phenyl]-3-phenyl-1-propanone β-D-Glucuronide; Propafenone Metabolite Glucuronide; Propafenone-β-D-Glucuronide; Propafenone D-Glucuronide; Propafenone Impurity G; Propafenone Related Compound G
EINECS	Contact for details

Quality Control

Every batch of Propafenone Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to confirm structure, purity, and conformity to customer specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Assay (HPLC)	90.0% - 110.0% of labeled amount

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