Description

Warfarin Impurity 1 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the widely used anticoagulant drug, Warfarin, by serving as a key marker in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on compliance and analytical method development.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Warfarin Sodium API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or GC methods for Warfarin analysis.
• Quality Control & Assurance: Employed in routine QC testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Warfarin to understand its degradation pathways.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in academic and industrial research to study the metabolism, pharmacokinetics, and synthesis pathways of Warfarin and related compounds.

Basic Information

Product Name	Warfarin Impurity 1
CAS No.	55901-61-6
Molecular Formula	C19H16O4
Molecular Weight	308.33 g/mol
Synonyms	4-Hydroxy-3-(3-oxo-1-phenylbutyl)-2H-1-benzopyran-2-one; Warfarin Related Compound A; Warfarin Impurity A; 3-(α-Acetonylbenzyl)-4-hydroxycoumarin; 4-Hydroxy-3-(1-phenyl-3-oxobutyl)coumarin; NSC 59864; Warfarin EP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Warfarin Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with relevant pharmacopeial guidelines (USP, EP) and ICH Q3A/B standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results of all analytical tests, including HPLC purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
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 ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.