Description

Anethole Impurity 1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety profile of anethole, a widely used flavor and fragrance ingredient. It is primarily required by analytical laboratories and manufacturers in the pharmaceutical, flavor & fragrance, and food additive industries for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of related substances in active pharmaceutical ingredients (APIs) and finished drug products containing anethole or its derivatives.
• Flavor & Fragrance Quality Control: Serves as a critical benchmark in Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC) methods to monitor and control impurity levels in natural and synthetic anethole.
• Method Development & Validation: Essential for developing, calibrating, and validating analytical methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and flavor safety assessments (FEMA).
• Research & Development: Used in metabolic studies, stability testing, and degradation pathway analysis of anethole-based compounds.
• Calibration Standard: Acts as a primary standard for calibrating analytical instrumentation to ensure accurate and reproducible results in quality control laboratories.

Basic Information

Item	Detail
Product Name	Anethole Impurity 1
CAS No.	22191-62-4
Molecular Formula	C10H12O
Molecular Weight	148.20 g/mol
Synonyms	1-Methoxy-4-(1-propenyl)benzene; 4-Propenylanisole; Anethole Related Compound A; Anethole EP Impurity A; Anethole USP Related Compound; p-Propenylanisole; Isoanethole (isomer); trans-Anethole Impurity
EINECS	Contact for details

Quality Control

Every batch of Anethole Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using validated methods (HPLC, GC, NMR) to ensure compliance with pharmaceutical (USP/EP) and analytical reference standard requirements. 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 in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline 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%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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