Description

Dobutamine Impurity 2 CAS NO 61413-41-0 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the cardiovascular drug Dobutamine. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in method development, stability studies, and regulatory compliance for Dobutamine-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Analytical Method Development: Used in developing and optimizing High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for Dobutamine analysis.
• Quality Control & Assurance: Employed as a system suitability and identification marker in the routine QC testing of Dobutamine Active Pharmaceutical Ingredient (API) and finished drug products.
• Stability Studies: Acts as a marker impurity to monitor the degradation profile of Dobutamine under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Provides necessary impurity data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research & Development: Utilized in pharmacokinetic and metabolic studies to understand the fate of related substances in biological systems.

Basic Information

Product Name	Dobutamine Impurity 2
CAS No.	61413-41-0
Molecular Formula	C18H23NO3
Molecular Weight	301.38 g/mol
Synonyms	4-[2-[[3-(4-Hydroxyphenyl)-1-methylpropyl]amino]ethyl]pyrocatechol; 1-(3,4-Dihydroxyphenyl)-2-[[3-(4-hydroxyphenyl)-1-methylpropyl]amino]ethanone; Dobutamine Related Compound B; Dobutamine EP Impurity B; Dobutamine USP Related Compound B; Desmethyldobutamine; A-6
EINECS	Contact for details

Quality Control

Every batch of Dobutamine Impurity 2 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with each shipment. Our quality commitment aligns with the requirements for reference standards used in cGMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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