Description

Dobutamine Impurity D CAS NO 82473-36-7 is a high-purity chemical reference standard used for the identification and quantification of a specific process-related impurity in the active pharmaceutical ingredient (API) Dobutamine. This compound is critical for ensuring the quality, safety, and efficacy of Dobutamine-based pharmaceutical formulations by enabling precise analytical control during development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method validation and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development and validation (HPLC, LC-MS) in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine batch release testing of Dobutamine API to monitor and control the level of this specific impurity, ensuring it remains within specified safety thresholds.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity profiles and justify specification limits.
• Stability Studies: Employed as an analytical marker to track the formation or increase of Dobutamine Impurity D over time under various stress conditions, supporting shelf-life determination.
• Process Chemistry Research: Serves as a key marker to optimize synthesis and purification processes, helping to minimize the formation of this impurity.
• Contract Research Organizations (CROs): Utilized by analytical service providers to offer validated testing services for clients in the pharmaceutical industry.

Basic Information

Product Name	Dobutamine Impurity D
CAS No.	82473-36-7
Molecular Formula	C₁₈H₂₃NO₃
Molecular Weight	301.38 g/mol
Synonyms	4-[2-[[1-Methyl-3-(4-hydroxyphenyl)propyl]amino]ethyl]benzene-1,2-diol; 3,4-Dihydroxy-α-[[[3-(4-hydroxyphenyl)-1-methylpropyl]amino]methyl]benzyl alcohol; Dobutamine Related Compound D; Dobutamine EP Impurity D; Dobutamine USP Impurity D; (RS)-Dobutamine Impurity D; 1,2-Benzenediol, 4-[2-[[1-methyl-3-(4-hydroxyphenyl)propyl]amino]ethyl]-
EINECS	Contact for details

Quality Control

Every batch of Dobutamine Impurity D is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques such as HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability. Our quality commitment aligns with the principles of cGMP and relevant ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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 single unknown impurity ≤ 0.5%
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.