Description

Dobutamine Impurity 3 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 benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in quality control, research and development, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Dobutamine Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing, optimizing, and validating chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure compliance with ICH guidelines.
• Regulatory Submissions & Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products in Dobutamine formulations under various stress conditions.
• Research & Development: Facilitates chemical and pharmacological research into the metabolism, degradation pathways, and synthesis of Dobutamine-related compounds.

Basic Information

Product Name	Dobutamine Impurity 3
CAS No.	334947-75-0
Molecular Formula	C18H23NO3
Molecular Weight	301.38 g/mol
Synonyms	1-(3,4-Dihydroxyphenyl)-2-[[1-methyl-3-(4-hydroxyphenyl)propyl]amino]butan-1-one; Dobutamine Related Compound C; Dobutamine EP Impurity C; Dobutamine USP Impurity; 4-[2-[[1-Methyl-3-(4-hydroxyphenyl)propyl]amino]butyryl]benzene-1,2-diol; (RS)-Dobutamine Impurity 3; Dobutamine Impurity C
EINECS	Contact for details

Quality Control

Every batch of Dobutamine Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic techniques, to ensure high purity and accurate identification, aligning with ICH Q3A, Q3B, and pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing identity, purity, and assay results is provided with each shipment.

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 absorption of moisture.

Specification

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

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