Description

Norepinephrine Impurity 1 Hcl is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of Norepinephrine and its pharmaceutical salts. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by enabling accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing in accordance with ICH guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Norepinephrine API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Stability Studies: Employed as a marker to monitor degradation pathways and establish shelf-life specifications for Norepinephrine-based formulations.
• Process Chemistry Research: Used in research and development to study and optimize synthesis pathways, helping to minimize impurity formation.
• Quality Assurance/Quality Control (QA/QC): A vital component for in-house quality control testing to ensure batch-to-batch consistency and purity of the final API.

Basic Information

Product Name	Norepinephrine Impurity 1 Hcl
CAS No.	3868-81-3
Molecular Formula	C8H12ClNO3
Molecular Weight	205.64 g/mol
Synonyms	Noradrenaline Impurity 1 Hydrochloride; 3,4-Dihydroxy-α-((methylamino)methyl)benzyl alcohol hydrochloride; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanol hydrochloride impurity; DL-Norepinephrine impurity 1 HCl; Arterenol Impurity 1 HCl; Levarterenol Impurity 1 HCl; (R*,S*)-4-(2-Amino-1-hydroxyethyl)-1,2-benzenediol hydrochloride
EINECS	Contact for details

Quality Control

Our Norepinephrine Impurity 1 Hcl is manufactured under strict quality systems suitable for pharmaceutical reference standard applications. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each lot, documenting compliance with in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment ensures material suitable for regulatory filing and cGMP environments.

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 under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches 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.