Description

Dobutamine Impurity 4 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 Dobutamine by serving as a key marker in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments focused on compliance and product development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Dobutamine Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods in compliance with ICH guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and adherence to pharmacopeial specifications (USP/EP).
• Stability Studies: Employed to track the formation of degradation products in Dobutamine formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Synthesis: Serves as a building block or intermediate in synthetic chemistry research for developing novel analogs or studying metabolic pathways.

Basic Information

Product Name	Dobutamine Impurity 4
CAS No.	334947-73-8
Molecular Formula	C18H23NO3
Molecular Weight	301.38 g/mol
Synonyms	4-(2-((4-Hydroxyphenyl)amino)ethyl)-1,2-benzenediol; 4-(2-(4-Hydroxyanilino)ethyl)benzene-1,2-diol; Dobutamine Related Compound; Dobutamine EP Impurity D; Dobutamine USP Impurity; Dobutamine Degradation Product; (RS)-4-(2-((4-Hydroxyphenyl)amino)ethyl)pyrocatechol
EINECS	Contact for details

Quality Control

Our Dobutamine Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed 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
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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