Description

Levalbuterol Related Compound B (20 Mg) (α-[{(1,1-Dimethylethyl)Amino}Methyl]-4-Hydroxy-3-Methyl-Benzenemethanol) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound is critical for the accurate identification and quantification of impurities in Levalbuterol drug substances and finished products, ensuring compliance with stringent regulatory requirements. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the development and quality assurance of respiratory medications.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Levalbuterol HCl active pharmaceutical ingredients (APIs) and inhalation solutions.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or GC analytical methods for purity and stability-indicating assays.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure drug products meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to track the formation of related substances under various environmental conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies for Levalbuterol-based drugs.
• Research & Development: Utilized in synthetic chemistry R&D to understand degradation pathways and improve the synthesis and purification processes of Levalbuterol.

Basic Information

Item	Details
Product Name	Levalbuterol Related Compound B (20 Mg) (α-[{(1,1-Dimethylethyl)Amino}Methyl]-4-Hydroxy-3-Methyl-Benzenemethanol)
CAS No.	18910-68-4
Molecular Formula	C13H21NO2
Molecular Weight	223.31 g/mol
Synonyms	4-Hydroxy-3-methyl-α-[[(1,1-dimethylethyl)amino]methyl]benzenemethanol; (R)-4-Hydroxy-3-methyl-α-[[(1,1-dimethylethyl)amino]methyl]benzenemethanol; Levalbuterol Impurity B; (R)-Terbutaline; Levosalbutamol Related Compound B; (R)-α-[(tert-Butylamino)methyl]-4-hydroxy-3-methylbenzyl alcohol; 1-(3,4-Dihydroxyphenyl)-2-(tert-butylamino)ethanol isomer
EINECS	Contact for details

Quality Control

Every batch of Levalbuterol Related Compound B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and potency, aligning with pharmaceutical reference standard expectations. Comprehensive Certificates of Analysis (COA) detailing results from HPLC, NMR, and mass spectrometry are provided to guarantee traceability and compliance with your research and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content	≤ 0.5%
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.