Description

Dopamine Impurity 8 is a high-purity chemical reference standard, specifically identified as a known impurity of the neurotransmitter and pharmaceutical agent Dopamine. This compound is critical for analytical method development and validation, ensuring the safety and efficacy of pharmaceutical products. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in the synthesis, purification, and regulatory compliance of Dopamine and related compounds.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Dopamine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurities during the manufacturing process.
• Quality Control & Assurance: Serves as a system suitability component and a calibrant in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products in Dopamine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Synthesis: Used by chemists to study metabolic pathways, synthesis by-products, and to optimize purification processes for Dopamine.

Basic Information

Item	Details
Product Name	Dopamine Impurity 8
CAS No.	16240-59-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dopamine Related Compound 8; Dopamine Impurity B; 1-(3,4-Dihydroxyphenyl)-2-aminoethanol Impurity; 3,4-Dihydroxyphenethylamine Impurity 8; 4-(2-Aminoethyl)benzene-1,2-diol Impurity; 2-(3,4-Dihydroxyphenyl)ethylamine Impurity; Hordenine Impurity (related); Potential process-related impurity of Dopamine HCl
EINECS	Contact for details

Quality Control

Every batch of Dopamine Impurity 8 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Keep the container sealed to prevent moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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