Description

Norepinephrine Ep Impurity D CAS NO 1932110-67-2 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, production, and quality assurance of Norepinephrine and related pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Norepinephrine drug substances and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Acts as a marker to track impurity formation during forced degradation and long-term stability studies of drug formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Norepinephrine Ep Impurity D
CAS No.	1932110-67-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Norepinephrine Impurity D; EP Impurity D of Norepinephrine; Norepinephrine Related Compound D; Noradrenaline Impurity D; (R)-4-(2-Amino-1-hydroxyethyl)benzene-1,2-diol Impurity D; 1,2-Benzenediol, 4-(2-amino-1-hydroxyethyl)-, (R)-, Impurity D; Norepinephrine Bitartrate Impurity D
EINECS	Contact for details

Quality Control

Every batch of Norepinephrine Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial guidelines (EP, USP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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%
Residual Solvents (GC)	Complies with ICH Q3C

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