Description

Dobutamine Impurity 1 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. The product is supplied with comprehensive analytical data to support its use in regulated environments.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Dobutamine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Dobutamine.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Facilitates chemical and metabolic studies related to Dobutamine, aiding in the understanding of its degradation pathways and pharmacokinetics.

Basic Information

Product Name	Dobutamine Impurity 1
CAS No.	334947-74-9
Molecular Formula	C18H23NO3
Molecular Weight	301.38 g/mol
Synonyms	4-[2-[[1-Methyl-3-(4-hydroxyphenyl)propyl]amino]ethyl]benzene-1,2-diol; Dobutamine Related Compound A; Dobutamine EP Impurity A; Dobutamine USP Impurity; 1-(3,4-Dihydroxyphenyl)-2-[[1-methyl-3-(4-hydroxyphenyl)propyl]amino]ethanone (Ketone Impurity); Desisobutyryl Dobutamine; Dobutamine Degradant
EINECS	Contact for details

Quality Control

Every batch of Dobutamine Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced techniques including HPLC, GC, MS, NMR, and IR spectroscopy. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive); therefore, containers should be kept in a dry environment and allowed to equilibrate to room temperature before opening to prevent moisture condensation.

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%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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