Description

Epinephrine Impurity 7 is a specified impurity of the critical pharmaceutical agent Epinephrine (Adrenaline). This compound is essential for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Epinephrine-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Epinephrine Active Pharmaceutical Ingredient (API) and finished drug products.
• Method Development and Validation: Critical for developing and validating sensitive analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure compliance with stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the product's impurity profile.
• Process Chemistry Research: Aids in optimizing synthetic and purification processes for Epinephrine to minimize the formation of this impurity.

Basic Information

Product Name	Epinephrine Impurity 7
CAS No.	62322-82-1
Molecular Formula	C9H11NO3
Molecular Weight	181.19 g/mol
Synonyms	Adrenaline Impurity 7; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanone; 3',4'-Dihydroxy-2-(methylamino)acetophenone; Epinephrine Related Compound 7; Adrenaline Related Compound A; Noradrenalone; α-(Methylamino)-3,4-dihydroxyacetophenone
EINECS	Contact for details

Quality Control

Every batch of Epinephrine Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment and is available upon request.

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 should be handled in a dry environment to prevent 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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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