Description

Dobutamine Impurity 5 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 for impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, R&D departments, and regulatory bodies involved in the development and manufacturing of injectable drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Dobutamine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to monitor process-related impurities and degradation products.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure compliance with pharmacopeial monographs (e.g., USP, EP, ICH Q3A/B guidelines) and internal specifications.
• Stability Studies: Employed as a marker to track impurity formation and profile changes in Dobutamine formulations under various stress and long-term storage conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing characterized impurity data required for drug approval.
• Research on Degradation Pathways: Facilitates studies on the chemical stability and degradation mechanisms of Dobutamine.

Basic Information

Product Name	Dobutamine Impurity 5
CAS No.	334947-72-7
Molecular Formula	C18H23NO3
Molecular Weight	301.38 g/mol
Synonyms	Dobutamine Related Compound 5; 4-[2-[[1-Methyl-3-(4-hydroxyphenyl)propyl]amino]ethyl]pyrocatechol; 1,2-Benzenediol, 4-[2-[[1-methyl-3-(4-hydroxyphenyl)propyl]amino]ethyl]-; Dobutamine EP Impurity B; Dobutamine USP Impurity 5; Dobutamine Impurity B; (RS)-Dobutamine Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Dobutamine Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques like HPLC and LC-MS to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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