Description

Levalbuterol Related Compound C (30 Mg) (α-[{(1,1-Dimethylethyl)Amino}Methyl]-4-Hydroxy-3-(Methoxymethyl)-Benzenemethanol) is a high-purity reference standard and pharmaceutical intermediate critical for analytical and research purposes. This compound is essential for ensuring the quality, safety, and efficacy of levalbuterol, a widely used bronchodilator, by serving as a key marker for impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for rigorous quality control and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Levalbuterol API and finished drug products according to ICH guidelines.
• Analytical Method Development & Validation: A critical component for developing, validating, and verifying HPLC, UPLC, and GC methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor process-related impurities in pharmaceutical manufacturing.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data for impurity characterization and control strategies.
• Research & Development (R&D): Utilized in stability studies, degradation pathway elucidation, and synthetic chemistry research for levalbuterol analogs.
• Pharmacopoeial Testing: Employed in testing to meet the specifications of pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).

Basic Information

Product Name	Levalbuterol Related Compound C (30 Mg) (α-[{(1,1-Dimethylethyl)Amino}Methyl]-4-Hydroxy-3-(Methoxymethyl)-Benzenemethanol)
CAS No.	18910-70-8
Molecular Formula	C13H21NO3
Molecular Weight	239.31 g/mol
Synonyms	1-(3,4-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol impurity C; (R)-Albuterol Related Compound C; Levosalbutamol Related Substance C; (R)-α-[(tert-Butylamino)methyl]-4-hydroxy-3-(hydroxymethyl)benzyl alcohol; 4-Hydroxy-3-(hydroxymethyl)-α-[[(1,1-dimethylethyl)amino]methyl]benzenemethanol; Levalbuterol EP Impurity C; Levalbuterol USP Related Compound C
EINECS	Contact for details

Quality Control

Our Levalbuterol Related Compound C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

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 should be handled in a dry environment to maintain stability and purity.

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.