Description

2-[(1,1-Dimethylethyl)(Phenylmethyl)Amino]-1-[4-Hydroxy-3-(Hydroxy-Methyl)Phenyl]Ethanonesalbutamol is a key pharmaceutical intermediate and reference standard of significant importance in the synthesis of active pharmaceutical ingredients (APIs). This compound matters for its role in ensuring the quality, consistency, and regulatory compliance of final drug products, particularly in the respiratory therapeutic area. It is primarily needed by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development, production, and quality control of advanced medications.

Application

• Pharmaceutical Intermediate: Critical building block in the synthetic pathway for Salbutamol (Albuterol) and related bronchodilator APIs.
• Reference Standard: Used as a high-purity calibrant in analytical methods (HPLC, GC) for identity, assay, and impurity profiling of drug substances and products.
• Process Development & Research: Serves as a key reagent in process chemistry research, route scouting, and optimization for scale-up manufacturing.
• Quality Control & Assurance: Essential for method validation, stability studies, and ensuring batch-to-batch consistency in GMP environments.
• Regulatory Submissions: Provides necessary chemical reference material for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Item	Details
Product Name	2-[(1,1-Dimethylethyl)(Phenylmethyl)Amino]-1-[4-Hydroxy-3-(Hydroxy-Methyl)Phenyl]Ethanonesalbutamol
CAS No.	64092-10-0
Molecular Formula	C22H29NO4
Molecular Weight	371.47 g/mol
Synonyms	Salbutamol Impurity; Albuterol Related Compound; 2-[(tert-Butyl)(benzyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanone; 64092-10-0; tert-Butylbenzylamino hydroxy(hydroxymethyl)phenylethanone; Salbutamol EP Impurity; Albuterol USP Related Substance
EINECS	Contact for details

Quality Control

Our 2-[(1,1-Dimethylethyl)(Phenylmethyl)Amino]-1-[4-Hydroxy-3-(Hydroxy-Methyl)Phenyl]Ethanonesalbutamol is produced under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical development and manufacturing. Certificates of Analysis (COA) are provided, detailing purity, identity, and impurity profiles as determined by HPLC, NMR, and MS. We support compliance with ICH guidelines and relevant pharmacopeial standards (USP, EP).

Storage

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

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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