Description

Norepinephrine Impurity 23 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 an essential tool for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing. The compound is supplied with full analytical characterization to support method validation and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Norepinephrine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product consistency and meeting pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Norepinephrine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Facilitates metabolic and pharmacokinetic studies by helping to identify and characterize potential impurity-related metabolites.

Basic Information

Product Name	Norepinephrine Impurity 23
CAS No.	1528622-09-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Noradrenaline Impurity 23; 1,2-Benzenediol, 4-[(1R)-2-amino-1-hydroxyethyl]-, Impurity 23; Norepinephrine Related Compound 23; (R)-4-(2-Amino-1-hydroxyethyl)benzene-1,2-diol Impurity; Adrenaline Impurity F (related); Levophed Impurity; Arterenol Impurity
EINECS	Contact for details

Quality Control

Every batch of Norepinephrine Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH, and relevant pharmacopeial guidelines for pharmaceutical impurities.

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 under inert atmosphere or in a desiccator to maintain stability and purity. Keep the container tightly sealed when not in use.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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