Description

Etilefrine Impurity D is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Etilefrine, a sympathomimetic amine used in pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Etilefrine Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurities during stability studies.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure the specificity and accuracy of impurity assays for Etilefrine batches.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Research & Development (R&D): Used in pharmacokinetic, metabolic, and toxicological studies to understand the profile and impact of impurities.

Basic Information

Product Name	Etilefrine Impurity D
CAS No.	42146-10-1
Molecular Formula	C10H15NO2
Molecular Weight	181.23 g/mol
Synonyms	1-(3-Hydroxyphenyl)-2-(methylamino)ethanol; 3-Hydroxy-α-[(methylamino)methyl]benzyl alcohol; 1-(3-Hydroxyphenyl)-2-(methylamino)ethan-1-ol; Etilefrine Related Compound D; Etilefrine EP Impurity D; Etilefrine USP Impurity D; Etilefrine Impurity 4; (R*,S*)-1-(3-Hydroxyphenyl)-2-(methylamino)ethanol
EINECS	Contact for details

Quality Control

Our Etilefrine Impurity D is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use as a reference standard in compliance with current pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown 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.