Description

Adrenaline Impurity F is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of adrenaline (epinephrine) drug products by enabling the accurate identification and quantification of related substances. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical, biotechnology, and analytical laboratory sectors who require reliable impurity standards for method validation and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Adrenaline Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in adrenaline formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization as per ICH Q3A and Q3B guidelines.
• Quality Control Testing: Acts as a system suitability standard and for routine batch release testing of epinephrine and its derivatives.
• Research and Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop purification processes.

Basic Information

Product Name	Adrenaline Impurity F
CAS No.	78995-75-2
Molecular Formula	C9H11NO3
Molecular Weight	181.19 g/mol
Synonyms	Epinephrine Impurity F; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanone; Adrenalone Impurity; 3',4'-Dihydroxy-2-(methylamino)acetophenone; α-(Methylamino)-3,4-dihydroxyacetophenone; Noradrenalone; Oxedrine Related Compound F
EINECS	Contact for details

Quality Control

Every batch of Adrenaline Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance 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 should be kept in a desiccated environment. For long-term storage, consider storing under an inert atmosphere to prevent potential oxidative degradation.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.