Description

Levalbuterol Related Compound E (30 Mg) (α-[{(1,1-Dimethylethyl)Amino}Methyl]-3-(Ethoxy-Methyl)-4-Hydroxy-Benzenemethanol) is a high-purity reference standard critical for analytical method development and validation in the pharmaceutical industry. This compound serves as a key impurity or degradation product for Levalbuterol, enabling precise quality control and ensuring the safety and efficacy of the final drug product. It is essential for research and quality assurance laboratories involved in the synthesis, purification, and regulatory compliance of respiratory medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Levalbuterol HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor product purity and degradation pathways.
• Quality Control & Assurance: Used in routine batch testing to ensure compliance with pharmacopeial monographs (USP, EP, JP) and ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes by identifying and minimizing the formation of this specific related compound.

Basic Information

Product Name	Levalbuterol Related Compound E (30 Mg) (α-[{(1,1-Dimethylethyl)Amino}Methyl]-3-(Ethoxy-Methyl)-4-Hydroxy-Benzenemethanol)
CAS No.	754926-25-5
Molecular Formula	C16H27NO4
Molecular Weight	297.39 g/mol
Synonyms	Levalbuterol Impurity E; (R)-Albuterol Related Compound E; 1-(3-Ethoxymethyl-4-hydroxyphenyl)-2-(tert-butylamino)ethanol; α-[(tert-Butylamino)methyl]-3-(ethoxymethyl)-4-hydroxybenzenemethanol; (R)-α-[[(1,1-Dimethylethyl)amino]methyl]-3-(ethoxymethyl)-4-hydroxy-Benzenemethanol; R-albuterol impurity E; Levalbuterol EP Impurity E
EINECS	Contact for details

Quality Control

Our Levalbuterol Related Compound E is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant standards. Our quality commitment supports your needs for reliable and traceable materials in regulatory and research applications.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and handled under appropriate conditions to prevent degradation or absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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