Description

Epinephrine Impurity 1 Sodium Salt is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker in the analytical profiling of epinephrine (adrenaline) and its related drug substances and products. It is essential for quality control laboratories, regulatory compliance, and method validation in the pharmaceutical industry. Ensuring the identity and purity of this impurity is fundamental to guaranteeing the safety and efficacy of final drug formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Epinephrine API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (USP, EP, JP).
• Stability Studies: Used to track the formation and levels of this specific degradation product during drug substance and product stability testing under various conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Facilitates studies on the degradation pathways, synthesis, and metabolism of epinephrine and related catecholamines.

Basic Information

Product Name	Epinephrine Impurity 1 Sodium Salt
CAS No.	21093-14-1
Molecular Formula	C9H10NO3Na
Molecular Weight	203.17 g/mol
Synonyms	Adrenalone Impurity Sodium Salt; 3',4'-Dihydroxy-2-(methylamino)acetophenone Sodium Salt; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanone Sodium Salt; Epinephrine Related Compound A Sodium Salt; Adrenalone Sodium Salt; Noradrenalone Sodium Salt; α-(Methylamino)-3,4-dihydroxyacetophenone Sodium Salt
EINECS	Contact for details

Quality Control

Every batch of Epinephrine Impurity 1 Sodium Salt is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against stringent in-house specifications. We support compliance with ICH Q3A/B guidelines and pharmacopeial standards for impurity qualification.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
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.