Description

Phenprocoumon Impurity 1 is a high-purity reference standard of a specified impurity associated with the anticoagulant drug Phenprocoumon. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Phenprocoumon active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity levels during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Used in metabolic and toxicological studies to understand the profile and impact of drug-related impurities.

Basic Information

Product Name	Phenprocoumon Impurity 1
CAS No.	15074-20-1
Molecular Formula	C₁₇H₁₄O₃
Molecular Weight	266.29 g/mol
Synonyms	4-Hydroxy-3-(1-phenylpropyl)-2H-1-benzopyran-2-one; Phenprocoumon Related Compound A; 3-(1-Phenylpropyl)-4-hydroxycoumarin; Marcoumar Impurity 1; Phenprocoumon EP Impurity A; Phenprocoumon USP Related Compound A; 4-Hydroxy-3-(1-phenylpropyl)coumarin
EINECS	Contact for details

Quality Control

Every batch of Phenprocoumon Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

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 ≤ 1.0%
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.