Description

Nadolol Ep Impurity E CAS NO 67247-33-0 is a specified impurity of the β-blocker pharmaceutical Nadolol, identified by its unique CAS registry number. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by analytical chemists, quality assurance professionals, and regulatory affairs specialists in the pharmaceutical and contract research organization (CRO) sectors to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nadolol Ep Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling of Nadolol.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure Nadolol API meets pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize the formation of this impurity during Nadolol synthesis.

Basic Information

Product Name	Nadolol Ep Impurity E
CAS No.	67247-33-0
Molecular Formula	C17H27NO4
Molecular Weight	309.40 g/mol
Synonyms	5-[3-[(1,1-Dimethylethyl)amino]-2-hydroxypropoxy]-1,2,3,4-tetrahydro-2,3-naphthalenediol; Nadolol Impurity E; Nadolol Related Compound E; Nadolol EP Impurity E; (2R,3S)-5-[3-[(1,1-Dimethylethyl)amino]-2-hydroxypropoxy]-1,2,3,4-tetrahydro-2,3-naphthalenediol; SQ 11725 Impurity E
EINECS	Contact for details

Quality Control

Every batch of Nadolol Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting regulatory requirements for pharmaceutical development and quality control.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% 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.