Description

Norepinephrine Impurity 34 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 development and validation of analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, quality control, and regulatory compliance of norepinephrine and related active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in norepinephrine drug substances and finished products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate detection and measurement of impurities.
• Quality Control (QC) and Quality Assurance (QA): Serves as a system suitability standard and a calibrant in routine QC testing to monitor batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation and level of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to define impurity limits and justify specifications.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and in metabolic studies to understand the fate of related compounds.

Basic Information

Product Name	Norepinephrine Impurity 34
CAS No.	1824725-09-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Noradrenaline Impurity 34; Norepinephrine Related Compound 34; (1R,2S)-1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanol impurity; Levarterenol Impurity 34; Arterenol Impurity 34; L-Norepinephrine Impurity 34; Adrenergic Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Norepinephrine Impurity 34 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, identification (IR/ NMR), and residual solvent analysis. Our quality commitment supports compliance with ICH Q3A, Q3B, and Q6A guidelines for pharmaceutical impurities.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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