Description

Adrenaline Impurity 5 is a high-purity chemical reference standard used in the analytical profiling of epinephrine (adrenaline) and its related pharmaceutical compounds. This impurity standard is critical for ensuring the safety, efficacy, and regulatory compliance of adrenaline-based drug products by enabling accurate identification and quantification of process-related impurities. It is an essential tool for quality control laboratories and research institutions in the pharmaceutical industry focused on method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Epinephrine API and finished drug products.
• HPLC/LC-MS Method Development & Validation: Critical for developing and validating chromatographic methods to separate and quantify impurities in adrenaline.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to monitor impurity profiles in adrenaline formulations.
• Quality Control & Release Testing: Essential for routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines on impurities.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of epinephrine.

Basic Information

Product Name	Adrenaline Impurity 5
CAS No.	70063-06-8
Molecular Formula	C9H11NO3
Molecular Weight	181.19 g/mol
Synonyms	Epinephrine Impurity 5; Adrenaline Related Compound 5; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanone; 3',4'-Dihydroxy-2-(methylamino)acetophenone; Adrenalone Impurity; Noradrenalone; α-Methylamino-3,4-dihydroxyacetophenone
EINECS	Contact for details

Quality Control

Every batch of Adrenaline Impurity 5 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and control of specific impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment ensures material suitability for its intended use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This compound is light-sensitive (store away from light) and may be hygroscopic (moisture-sensitive); ensure containers are sealed tightly after each use to prevent moisture absorption and degradation.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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