Description

Nadolol Ep Impurity G CAS NO 33841-03-1 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the β-blocker drug Nadolol by accurately identifying and quantifying process-related impurities. It is an essential tool for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and fine chemical industries who require reliable standards for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Nadolol-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Nadolol.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate product purity and control strategy.
• Research & Development: Used in synthetic chemistry research to study reaction mechanisms and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Nadolol Ep Impurity G
CAS No.	33841-03-1
Molecular Formula	C17H27NO4
Molecular Weight	309.40 g/mol
Synonyms	5-[3-(tert-Butylamino)-2-hydroxypropoxy]-1,2,3,4-tetrahydro-2,3-naphthalenediol; Nadolol Impurity G; Nadolol Related Compound G; Nadolol EP Impurity G; (2R,3S)-5-[2-Hydroxy-3-[(1,1-dimethylethyl)amino]propoxy]-1,2,3,4-tetrahydro-2,3-naphthalenediol; Nadolol Isomer; Nadolol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Nadolol Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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