Description

Adrenaline Impurity 9 Hcl 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 adrenaline (epinephrine) pharmaceutical products by serving as a known impurity marker. It is essential for analytical laboratories in the pharmaceutical industry, particularly those focused on method development, validation, and regulatory compliance testing for adrenergic drugs.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Impurity 9 in adrenaline and related drug substances and products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing of active pharmaceutical ingredients (APIs) and finished drug formulations to monitor impurity levels against ICH guidelines.
• Regulatory Compliance and Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Used as an analytical standard to track the formation of this specific impurity during forced degradation and long-term stability studies of adrenaline-based products.
• Research and Development: Facilitates chemical and pharmacological research into the degradation pathways and metabolism of adrenaline.

Basic Information

Product Name	Adrenaline Impurity 9 Hcl
CAS No.	189506-42-1
Molecular Formula	C9H11NO3 • HCl
Molecular Weight	217.65 g/mol (Free base: 181.19 g/mol)
Synonyms	Epinephrine Impurity 9 Hydrochloride; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanone Hydrochloride; Adrenalone Impurity; Adrenalone Related Compound; Noradrenalone Hydrochloride; 3',4'-Dihydroxy-2-(methylamino)acetophenone Hydrochloride; (3,4-Dihydroxyphenyl)-2-(methylamino)ethanone HCl
EINECS	Contact for details

Quality Control

Our Adrenaline Impurity 9 Hcl is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%

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