Description

Norepinephrine Impurity 2 CAS NO 408328-15-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a known impurity in the analysis of Norepinephrine and related APIs. It is an essential material for pharmaceutical R&D, quality control laboratories, and regulatory compliance activities. This impurity standard supports method development, validation, and stability studies in drug manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Norepinephrine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for the accurate identification and quantification of impurities.
• Stability Studies & Forced Degradation Testing: Employed as a marker to study the degradation pathways and shelf-life of Norepinephrine-based formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity profiles and characterization data.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (USP, EP, BP) that specify limits for known and unknown impurities.
• Academic & Contract Research: Serves as a key reagent in university and CRO settings for research into catecholamine chemistry, metabolism, and analytical techniques.

Basic Information

Product Name	Norepinephrine Impurity 2
CAS No.	408328-15-4
Molecular Formula	C8H11NO3
Molecular Weight	169.18 g/mol
Synonyms	Noradrenaline Impurity 2; (R)-4-(2-Amino-1-hydroxyethyl)benzene-1,2-diol; 1,2-Benzenediol, 4-(2-amino-1-hydroxyethyl)-, (R)-; Norepinephrine Related Compound B; LEVONOREPINEPHRINE IMPURITY B; Norepinephrine EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Norepinephrine Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to the highest standards suitable for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and relevant pharmacopoeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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