Description

Adrenaline Ep Impurity E Hcl is a high-purity reference standard and pharmaceutical impurity critical for analytical research and development. This compound is essential for ensuring the quality, safety, and regulatory compliance of Adrenaline (Epinephrine) drug substances and finished products. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Impurity E in Adrenaline/Epinephrine API and formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component for developing, calibrating, and validating chromatographic methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Adrenaline products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research & Development: Aids in synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Adrenaline Ep Impurity E Hcl
CAS No.	317351-39-6
Molecular Formula	C9H11NO3 • HCl
Molecular Weight	217.65 g/mol (Free base: 181.19 g/mol)
Synonyms	Epinephrine Impurity E Hydrochloride; Adrenaline Related Compound E HCl; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanone Hydrochloride; 3',4'-Dihydroxy-2-(methylamino)acetophenone Hydrochloride; Adrenalone Impurity; Noradrenalone Hydrochloride (related); Epinephrine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Adrenaline Ep Impurity E Hcl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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.