Description

Norepinephrine Impurity 7 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, ensuring the safety and efficacy of the final drug substance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

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 & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity detection in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Employed as a marker to track the formation of degradation products during forced degradation and long-term stability studies of norepinephrine formulations.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways and related substances of norepinephrine.

Basic Information

Product Name	Norepinephrine Impurity 7
CAS No.	2948-16-5
Molecular Formula	C8H11NO3
Molecular Weight	169.18 g/mol
Synonyms	Noradrenaline Impurity 7; 4-[(1R)-2-Amino-1-hydroxyethyl]benzene-1,2-diol (related isomer); Norepinephrine Related Compound 7; L-Norepinephrine Impurity; (R)-4-(2-Amino-1-hydroxyethyl)benzene-1,2-diol; Adrenaline Impurity Standard; Catecholamine Impurity; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Norepinephrine Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with ICH Q3A, Q3B, and pharmacopeial standards. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced analytical techniques including HPLC, GC, MS, and NMR. We support GMP and ISO 9001 aligned processes for traceability and consistency.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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