Description

Betaxolol Ep Impurity A CAS NO 67193-95-7 is a high-purity chemical reference standard specifically used in the analytical profiling of Betaxolol, a β-blocker medication. This impurity is critical for pharmaceutical quality control, enabling manufacturers to identify, quantify, and monitor this specific by-product during drug development and production. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference standards to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Betaxolol Ep Impurity A in Betaxolol active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Crucial for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) methods, in quality control laboratories.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to monitor the formation and levels of this impurity during forced degradation and long-term stability studies of Betaxolol formulations.
• Pharmacopoeial Testing: Employed to ensure compliance with pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for known and unknown impurities in Betaxolol.
• Research and Development: Serves as a key reagent in R&D for studying the degradation pathways and synthesis impurities of Betaxolol.

Basic Information

Product Name	Betaxolol Ep Impurity A
CAS No.	67193-95-7
Molecular Formula	C18H31NO3
Molecular Weight	309.45 g/mol
Synonyms	1-[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol Impurity A; Betaxolol Related Compound A; Betaxolol Impurity A; Betaxolol EP Impurity A; (RS)-1-[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol; Betaxolol Process Impurity; Betaxolol Degradant
EINECS	Contact for details

Quality Control

Every batch of Betaxolol Ep Impurity A is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results for purity, related substances, and other critical parameters.

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); the container must be kept tightly sealed in a dry environment to prevent degradation due to moisture absorption.

Specification

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

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