Description

Levalbuterol Related Compound E Hcl is a high-purity chemical reference standard and impurity used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of Levalbuterol, a widely used bronchodilator medication. It serves as an essential analytical tool for pharmaceutical manufacturers and quality control laboratories engaged in method development, validation, and regulatory compliance. The precise characterization of this related substance is fundamental for meeting stringent pharmacopeial standards and advancing respiratory therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Levalbuterol API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor process-related impurities.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Provides critical data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of degradation products under various stress conditions to establish product shelf life.
• Process Chemistry Research: Aids in optimizing synthetic pathways to minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Levalbuterol Related Compound E Hcl
CAS No.	69716-64-9
Molecular Formula	C13H22ClNO3 • HCl
Molecular Weight	304.23 g/mol (Free base: 263.77)
Synonyms	(1R,2S)-5-[2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl]-1,3-benzenediol hydrochloride; Levosalbutamol Related Compound E HCl; (R)-Salbutamol Related Substance E Hydrochloride; Albuterol Impurity E HCl; RS-1-[(1,1-Dimethylethyl)amino]-3-[(4-hydroxy-1,6-benzenediol)methanol] hydrochloride; 2-(tert-Butylamino)-1-(3,5-dihydroxyphenyl)ethanol hydrochloride (isomer of Levalbuterol)
EINECS	Contact for details

Quality Control

Every batch of Levalbuterol Related Compound E Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. Certificates of Analysis (COA) are provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with ICH, USP, and EP guidelines, and specifications can be aligned with your specific pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. 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 matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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