Description

Warfarin Impurity CAS NO 13546-81-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the widely used anticoagulant drug, Warfarin. Pharmaceutical manufacturers, analytical laboratories, and research institutions require this impurity standard for method development, validation, and routine quality control testing. Its availability supports the stringent impurity profiling mandated by global pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Primary use as a certified reference standard for the identification and quantification of related substances in Warfarin Sodium API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and QC labs to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing data for impurity identification and qualification as per FDA, EMA, and other health authority requirements.
• Stability Studies: Employed to track the formation of degradation products in Warfarin under various stress conditions (e.g., heat, light, humidity).
• Academic & Contract Research: Serves as a key reagent in university and CRO settings for pharmacological research and studies on Warfarin's metabolism and degradation pathways.

Basic Information

Product Name	Warfarin Impurity
CAS No.	13546-81-1
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; Warfarin Impurity A (in some references); 3-(α-Acetonylbenzyl)-4-hydroxycoumarin Impurity; 4-Hydroxy-3-(1-phenyl-3-oxobutyl)coumarin; Benzylwarfarin; Phenprocoumon Related Substance
EINECS	Contact for details

Quality Control

Every batch of Warfarin Impurity CAS NO 13546-81-1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and GC-MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents, supporting compliance with ICH guidelines and pharmacopeial expectations.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15°C and 25°C (59°F and 77°F), in a dry environment. Keep the container sealed to prevent moisture absorption and contamination.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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