Description

Acebutolol Dimer Impurity is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of dimeric impurities during the manufacturing and quality assurance of the β-blocker drug, Acebutolol. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Critical component in impurity profiling and stability studies of Acebutolol API (Active Pharmaceutical Ingredient) and finished dosage forms.
• Used for calibrating HPLC, UPLC, and LC-MS systems to ensure accurate impurity quantification.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Essential for quality control testing in pharmaceutical manufacturing to monitor and control impurity levels.
• Valuable for academic and contract research organizations (CROs) conducting pharmaceutical impurity research.

Basic Information

Product Name	Acebutolol Dimer Impurity
CAS No.	1330165-98-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acebutolol Dimer; Acebutolol Impurity Dimer; Acebutolol Related Compound Dimer; Bis(acebutolol) Impurity; Dimeric Impurity of Acebutolol; 1-[4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]butan-1-one Dimer; Acebutolol Dimer Related Substance
EINECS	Contact for details

Quality Control

Every batch of Acebutolol Dimer Impurity 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. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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); ensure the container is kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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