Description

Adrenaline Impurity 10 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 for method development and validation. It is essential for analytical chemists, quality control laboratories, and research scientists working in pharmaceutical development and regulatory compliance. The material is supplied with comprehensive analytical data to support its use in GMP environments.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analysis of Adrenaline (Epinephrine) API and finished drug products.
• Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC analytical methods to monitor impurities in compliance with ICH Q3A/B guidelines.
• Quality Control (QC) Testing: Employed in routine QC testing of pharmaceutical raw materials and finished products to ensure impurity profiles meet stringent specifications.
• Stability Studies: Used to identify and quantify degradation products in adrenaline formulations during forced degradation and long-term stability studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Serves as a key reagent in metabolic pathway studies and pharmacological research related to catecholamines.

Basic Information

Product Name	Adrenaline Impurity 10 Hcl
CAS No.	1416249-73-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Epinephrine Impurity 10 Hydrochloride; Adrenaline Related Compound 10 HCl; 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, hydrochloride (9CI); (R)-(-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride; Adrenaline HCl Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Adrenaline Impurity 10 Hcl is manufactured and tested under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) containing batch-specific data are available upon request to support your regulatory and quality needs.

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 (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Water Content	Contact for details
Residual Solvents	Complies with ICH limits

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