Description

Rac Des(Isopropylamino) Acebutolol Diol is a key chemical intermediate and impurity reference standard used in the synthesis and quality control of pharmaceutical compounds. This compound is of significant importance for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) derived from acebutolol and related β-blocker pathways. It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in drug development, process optimization, and regulatory compliance testing.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of acebutolol and its structural analogs.
• Reference Standard for Impurity Profiling: Used as a certified standard in HPLC, LC-MS, and other analytical methods to identify and quantify process-related impurities.
• Metabolite Studies: Employed in research to study the metabolic pathways and degradation products of β-adrenergic blocking agents.
• Process Development & Validation: Essential for developing, scaling, and validating robust API manufacturing processes.
• Quality Control (QC) & Quality Assurance (QA): Integral for establishing specifications and release criteria for pharmaceutical products in compliance with ICH guidelines.
• Regulatory Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary data on impurities and process controls.

Basic Information

Product Name	Rac Des(Isopropylamino) Acebutolol Diol
CAS No.	96480-91-0
Molecular Formula	C14H22N2O3
Molecular Weight	266.34 g/mol
Synonyms	1-(2-Acetyl-4-acetamidophenoxy)-3-(isopropylamino)-2-propanol Diol; Acebutolol Desisopropyl Impurity; Acebutolol Diol Derivative; Acebutolol Related Compound; (±)-Des(Isopropylamino) Acebutolol Diol; Rac-Desisopropylamino Acebutolol Diol; 2-Propanol, 1-[2-acetyl-4-(acetylamino)phenoxy]-3-[(1-methylethyl)amino]-; Acebutolol Impurity D
EINECS	Contact for details

Quality Control

Our Rac Des(Isopropylamino) Acebutolol Diol is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with specified parameters. We support compliance with ICH Q3A/B, USP, and other relevant pharmacopeial guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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