Description

Norepinephrine Impurity 24 Hcl 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 well-characterized impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development and quality control of Norepinephrine and related adrenergic drugs. The product is supplied with comprehensive analytical data to support regulatory compliance and method validation.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Norepinephrine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to monitor impurity formation in drug formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in pharmacological and metabolic research to study the pathways and by-products associated with Norepinephrine synthesis and degradation.
• Quality Control Testing: Acts as a system suitability standard and a quantitative calibrant in routine batch release testing of pharmaceutical ingredients.

Basic Information

Product Name	Norepinephrine Impurity 24 Hcl
CAS No.	373360-12-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Noradrenaline Impurity 24 Hydrochloride; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanol Impurity 24 HCl; Norepinephrine Related Compound 24; Adrenaline Impurity Standard; Levophed Impurity; (R)-4-(2-Amino-1-hydroxyethyl)benzene-1,2-diol Impurity; Arterenol Impurity
EINECS	Contact for details

Quality Control

Our Norepinephrine Impurity 24 Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data, supporting compliance with ICH Q3A, Q3B, and pharmacopeial standards. Our quality commitment ensures reliable and traceable reference materials for your critical applications.

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 must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity.

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	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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