Description

Etilefrine Impurity A is a designated impurity standard used in the analytical profiling and quality control of the pharmaceutical substance Etilefrine. This high-purity reference material is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of this specific impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Etilefrine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Employed as a marker to monitor the formation of this specific degradation product under various stress conditions.
• Pharmacopoeial Testing: Used in testing to comply with pharmacopoeial monographs (e.g., USP, EP) that specify impurity limits.
• Research & Development: Supports synthetic route optimization and process chemistry studies by identifying and tracking this impurity.

Basic Information

Product Name	Etilefrine Impurity A
CAS No.	22510-12-9
Molecular Formula	C10H15NO2
Molecular Weight	181.23 g/mol
Synonyms	2-[(Ethylamino)methyl]-5-hydroxybenzyl alcohol; 1-(3,5-Dihydroxyphenyl)-2-(ethylamino)ethanol impurity; Etilefrine Related Compound A; Etilefrine EP Impurity A; Etilefrine USP Impurity A; 5-Hydroxy-2-[(ethylamino)methyl]benzenemethanol; α-[(Ethylamino)methyl]-3,5-dihydroxybenzyl alcohol
EINECS	Contact for details

Quality Control

Every batch of Etilefrine Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assay, and impurity profiling via validated chromatographic methods. Certificates of Analysis (COA) providing detailed batch-specific results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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