Description

Levalbuterol Related Compound G (20 Mg) (Alpha[{(1,1-Dimethylethyl)Amino}Methyl]-4,5-Dihydroxy-1,3-Benzenedimethanol) is a high-purity analytical reference standard, specifically a related substance of the bronchodilator Levalbuterol. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification and quantification of process impurities and degradation products. It is primarily used by analytical chemists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and contract research organisation (CRO) sectors to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Method Development: Serves as a certified reference material for developing and validating analytical methods, particularly HPLC and UPLC, to monitor impurities in Levalbuterol API and finished dosage forms.
• Quality Control and Release Testing: Used as a system suitability standard and for quantitative analysis in routine QC labs to ensure Levalbuterol products meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies and Forced Degradation: Employed to identify and track the formation of this specific related compound during drug product stability testing under various ICH-prescribed conditions.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate comprehensive control of the drug substance.
• Contract Research and Testing Services: A vital tool for CROs and analytical service providers offering impurity identification and method validation services to pharmaceutical clients.
• Academic and Clinical Research: Supports investigative studies on the metabolism, pharmacokinetics, and degradation pathways of Levalbuterol and related β-2 agonists.

Basic Information

Product Name	Levalbuterol Related Compound G (20 Mg) (Alpha[{(1,1-Dimethylethyl)Amino}Methyl]-4,5-Dihydroxy-1,3-Benzenedimethanol)
CAS No.	182676-90-0
Molecular Formula	C13H21NO4
Molecular Weight	255.31 g/mol
Synonyms	1,3-Benzenedimethanol, α-[[(1,1-dimethylethyl)amino]methyl]-4,5-dihydroxy-; (R)-α-[[(1,1-Dimethylethyl)amino]methyl]-4,5-dihydroxy-1,3-benzenedimethanol; Levalbuterol Impurity G; (R)-Salbutamol Related Compound G; R-albuterol Related Substance G; (R)-α-[(tert-Butylamino)methyl]-4,5-dihydroxy-1,3-benzenedimethanol
EINECS	Contact for details

Quality Control

This analytical standard is manufactured under strict quality control conditions. Each batch is fully characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and ensure high purity. Our quality system is designed to support pharmaceutical and regulatory applications, with traceable documentation. Comprehensive Certificates of Analysis (COA) detailing purity, analytical methods, and batch-specific data are provided and available upon request.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccated conditions.

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 impurity ≤ 1.0%
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.