Description

Eugenol Impurity 3 (Eugenol EP Impurity C) is a high-purity chemical reference standard, specifically identified as an impurity of the natural compound eugenol. This material is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products and analytical methods. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in eugenol and eugenol-containing drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, GC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Batch Release: Serves as a system suitability standard in QC laboratories to ensure the accuracy and precision of impurity testing for raw materials and finished pharmaceutical products.
• Stability Studies: Employed to track the formation of degradation products in eugenol-based formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Natural Products: Used in academic and industrial research to study the chemistry, metabolism, and stability of eugenol and related phenylpropanoids.

Basic Information

Product Name	Eugenol Impurity 3 (Eugenol EP Impurity C)
CAS No.	103475-43-0
Molecular Formula	C10H12O2
Molecular Weight	164.20 g/mol
Synonyms	Eugenol Impurity C; Eugenol EP Impurity C; 2-Methoxy-4-(prop-1-en-1-yl)phenol; 4-Allyl-2-methoxyphenol impurity; 1-Allyl-4-hydroxy-3-methoxybenzene impurity; Eugenol related compound C; (E)-4-(Prop-1-en-1-yl)-2-methoxyphenol
EINECS	Contact for details

Quality Control

Every batch of Eugenol Impurity 3 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including confirmation of structure and high purity determination. A detailed Certificate of Analysis (COA) is supplied with each product, containing batch-specific results for identity, purity, and impurities. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

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 under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 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.