Description

Esmolol Impurity 19 is a designated chemical reference standard used in the analytical profiling of the pharmaceutical agent Esmolol Hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic and spectroscopic analyses. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers involved in the development and production of Esmolol and related β-blocker medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Esmolol Impurity 19 in Esmolol Hydrochloride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Critical component in developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) assays.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products in Esmolol formulations under various stress conditions (heat, light, humidity) to determine shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry by helping to identify and control process-related impurities.

Basic Information

Product Name	Esmolol Impurity 19
CAS No.	59576-95-3
Molecular Formula	C16H25NO4
Molecular Weight	295.38 g/mol
Synonyms	4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]benzenepropanoic acid methyl ester; Methyl 3-[4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]propanoate; Esmolol Related Compound; Esmolol Process Impurity; Esmolol Methyl Ester Impurity
EINECS	Contact for details

Quality Control

Every batch of Esmolol Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, NMR, and mass spectrometry to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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