Description

Esmolol Impurity 2 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the ultra-short-acting β-blocker Esmolol by serving as a key marker for impurity profiling and method validation. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams involved in drug development and manufacturing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Esmolol Impurity 2 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure specificity, accuracy, and precision in impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity fate and tolerance studies during Esmolol API synthesis.

Basic Information

Product Name	Esmolol Impurity 2 Hcl
CAS No.	98903-90-3
Molecular Formula	C16H25NO4 • HCl
Molecular Weight	331.84 g/mol (Free base: 295.37 g/mol)
Synonyms	Esmolol Related Compound 2; Esmolol EP Impurity B; Esmolol USP Impurity; Methyl 3-{4-[(2S)-2-hydroxy-3-(isopropylamino)propoxy]phenyl}propanoate hydrochloride; (S)-Methyl 3-[4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl]propionate hydrochloride; ASL-8052 Impurity; Brevibloc Impurity
EINECS	Contact for details

Quality Control

Our Esmolol Impurity 2 Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) detailing all test results against established specifications, supporting compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.