Description

Adrenaline Impurity 6 Hcl is a high-purity chemical reference standard, specifically identified as an impurity of the critical pharmaceutical agent, Adrenaline (Epinephrine). This compound is essential for analytical method development and validation, ensuring the safety and efficacy of adrenaline-based drug products. It is primarily used by pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments for precise impurity profiling and compliance testing.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material for the identification and quantification of Adrenaline Impurity 6 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or GC methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure product specifications meet pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Adrenaline.

Basic Information

Product Name	Adrenaline Impurity 6 Hcl
CAS No.	857565-22-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Epinephrine Impurity 6 Hydrochloride; Adrenaline Related Compound 6 HCl; 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, hydrochloride (9CI); (R)-(-)-Adrenaline Impurity 6 HCl; Adrenaline EP Impurity B HCl (potential); Adrenaline Process Impurity; AR-HCl-6
EINECS	Contact for details

Quality Control

Every batch of Adrenaline Impurity 6 Hcl CAS NO 857565-22-1 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH guidelines for pharmaceutical reference standards.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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