Description

Norepinephrine Tartrate Impurity 2 is a specified impurity of the active pharmaceutical ingredient Norepinephrine Tartrate, a critical sympathomimetic agent. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Norepinephrine Tartrate drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Norepinephrine Tartrate bulk drug and finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure API and drug product batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product 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 (NDA).
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Norepinephrine Tartrate Impurity 2
CAS No.	24159-36-2
Molecular Formula	C14H21NO9
Molecular Weight	347.32 g/mol
Synonyms	Noradrenaline Tartrate Impurity 2; (R)-4-(2-Amino-1-hydroxyethyl)benzene-1,2-diol tartrate impurity; L-Norepinephrine Tartrate Related Compound; 1,2-Benzenediol, 4-[(1R)-2-amino-1-hydroxyethyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1:1); Arterenol Tartrate Impurity; Levarterenol Tartrate Impurity B; (-)-Noradrenaline L-(+)-Tartrate Impurity
EINECS	Contact for details

Quality Control

Every batch of Norepinephrine Tartrate Impurity 2 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure it meets the high standards required for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming batch-specific data.

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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Specified impurity ≤ 1.0% Any unknown impurity ≤ 0.10% 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.