Description

Adrenaline Impurity 7 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) and related pharmaceutical products by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analysis of Adrenaline (Epinephrine) API and finished drug products.
• HPLC/LC-MS Calibration: Essential for developing and validating chromatographic methods to quantify impurity levels in compliance with ICH guidelines.
• Quality Control (QC) Testing: Employed in pharmaceutical QC labs to monitor and control the impurity profile of adrenaline batches.
• Research and Development (R&D): Used in stability studies and degradation pathway research to understand the behavior of adrenaline formulations.
• Regulatory Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identification and qualification.
• Method Transfer and Verification: Acts as a system suitability component when transferring analytical methods between laboratories or sites.

Basic Information

Product Name	Adrenaline Impurity 7 Hcl
CAS No.	29705-82-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Epinephrine Impurity 7 Hydrochloride; Adrenaline Related Compound 7 HCl; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanol impurity 7 hydrochloride; Adrenaline EP Impurity 7; Adrenaline USP Impurity 7; Epinephrine HCl Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Adrenaline Impurity 7 Hcl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identity, aligning with pharmacopeial expectations for reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets project requirements
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.