Description

Norepinephrine Impurity 9 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 containing Norepinephrine by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Norepinephrine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods in quality control laboratories.
• Pharmacopeial Compliance: Supports testing to comply with international pharmacopeia standards such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and ICH (International Council for Harmonisation) guidelines Q3A and Q3B on impurities.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Norepinephrine formulations.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies to agencies like the FDA and EMA.
• Research & Development: Used in academic and industrial R&D settings to study the synthesis, metabolism, and chemical behavior of Norepinephrine and related compounds.

Basic Information

Product Name	Norepinephrine Impurity 9 Hcl
CAS No.	1891319-98-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Noradrenaline Impurity 9 Hydrochloride; (R)-4-(2-Amino-1-hydroxyethyl)-1,2-benzenediol Impurity 9 HCl; Norepinephrine Related Compound 9; LEVOPHED Impurity 9; Arterenol Impurity 9; 1,2-Benzenediol, 4-[(1R)-2-amino-1-hydroxyethyl]-, hydrochloride (9CI); Norepinephrine HCl Impurity 9
EINECS	Contact for details

Quality Control

Our Norepinephrine Impurity 9 Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. Comprehensive Certificates of Analysis (COA) with detailed chromatographic data are provided for every batch to support your regulatory and quality assurance needs.

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 desiccants or inert atmosphere conditions to maintain 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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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