Description

Dobutamine Impurity 6 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the cardiovascular drug Dobutamine by serving as a known impurity for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control testing and compliance documentation.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dobutamine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure Dobutamine batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Dobutamine.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control.
• Research & Synthesis: Serves as a key intermediate or marker in synthetic chemistry research aimed at process optimization and impurity synthesis.

Basic Information

Product Name	Dobutamine Impurity 6
CAS No.	140165-60-2
Molecular Formula	C18H23NO3
Molecular Weight	301.38 g/mol
Synonyms	4-[2-[[3-(4-Hydroxyphenyl)-1-methylpropyl]amino]ethyl]pyrocatechol; Dobutamine Related Compound; 1,2-Benzenediol, 4-[2-[[3-(4-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-; Dobutamine EP Impurity; Dobutamine USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Dobutamine Impurity 6 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and spectroscopic identification, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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