Description

Norepinephrine Impurity 19 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for Norepinephrine-based drug substances and products. It is primarily utilized by researchers and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) 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, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of pharmaceutical preparations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Norepinephrine.
• Research & Development: Supports fundamental research in medicinal chemistry, pharmacology, and metabolism studies related to adrenergic agents.

Basic Information

Product Name	Norepinephrine Impurity 19 Hcl
CAS No.	3805-00-3
Molecular Formula	C8H12ClNO3 • HCl
Molecular Weight	254.10 g/mol (for hydrochloride salt)
Synonyms	Noradrenaline Impurity 19 Hydrochloride; 3,4-Dihydroxy-α-((methylamino)methyl)benzyl alcohol impurity; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanol Impurity 19 HCl; Norepinephrine Related Compound 19; L-Norepinephrine Impurity 19 Hydrochloride; Arterenol Impurity 19 HCl; Levophed Impurity 19 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Norepinephrine Impurity 19 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and research needs.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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