Description

Norepinephrine Impurity 18 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing norepinephrine. It is primarily utilized by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves 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 and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Norepinephrine to understand impurity formation pathways.
• Research and Development: Used in academic and industrial R&D for studying the metabolism, synthesis pathways, and degradation chemistry of Norepinephrine and related compounds.

Basic Information

Product Name	Norepinephrine Impurity 18 Hcl
CAS No.	2947-04-8
Molecular Formula	C8H12ClNO3 • HCl
Molecular Weight	250.10 g/mol (for hydrochloride salt)
Synonyms	Noradrenaline Impurity 18 Hydrochloride; 3,4-Dihydroxyphenylglycolamine Impurity; 1-(3,4-Dihydroxyphenyl)-2-aminoethanol impurity; Arterenol Impurity 18 HCl; Levarterenol Impurity 18; (R)-4-(2-Amino-1-hydroxyethyl)benzene-1,2-diol impurity hydrochloride; Norepinephrine Related Compound 18
EINECS	Contact for details

Quality Control

Every batch of Norepinephrine Impurity 18 Hcl is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) containing detailed results for identity, purity, and assay are available upon request.

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 and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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