Description

Acebutolol Ep Impurity J CAS NO 57898-79-0 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 cardiovascular drug Acebutolol by serving as a key impurity marker. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Acebutolol active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in compliance with ICH Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control impurity levels, ensuring drug product safety and meeting regulatory specifications.
• Stability Studies: Used to track the formation of degradation products in Acebutolol formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates studies on the metabolism, degradation pathways, and synthesis of Acebutolol and related compounds.

Basic Information

Product Name	Acebutolol Ep Impurity J
CAS No.	57898-79-0
Molecular Formula	C18H28N2O5
Molecular Weight	352.43 g/mol
Synonyms	1-(2-Acetyl-4-acetamidophenoxy)-3-(isopropylamino)-2-propanol; Acebutolol Related Compound J; Acebutolol EP Impurity J; Acebutolol Impurity J (EP); Acebutolol Metabolite Diacetate; N-[2-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]-4-acetylphenyl]acetamide
EINECS	Contact for details

Quality Control

Every batch of Acebutolol Ep Impurity J is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality commitment aligns with cGMP principles and pharmacopeial requirements (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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