Description

Norepinephrine Impurity 27 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of pharmaceutical products containing norepinephrine. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and stability studies to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: 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, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within GMP environments to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Norepinephrine.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy for drug substances.
• Research and Development: Used in preclinical and clinical research to study the metabolism, pharmacokinetics, and safety profile of Norepinephrine-related compounds.

Basic Information

Product Name	Norepinephrine Impurity 27
CAS No.	1894611-03-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Noradrenaline Impurity 27; (R)-4-(2-Amino-1-hydroxyethyl)benzene-1,2-diol Impurity 27; Levarterenol Impurity 27; Norepinephrine Related Compound 27; Arterenol Impurity 27; 1,2-Benzenediol, 4-[(1R)-2-amino-1-hydroxyethyl]-, Impurity 27; Adrenor Impurity 27
EINECS	Contact for details

Quality Control

Our Norepinephrine Impurity 27 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your regulatory and quality 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 should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
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 guidelines

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