Description

Betaxolol Impurity CAS NO 131564-70-0 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 Betaxolol by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists, quality assurance professionals, and research scientists working in pharmaceutical R&D and quality control laboratories. The impurity standard supports method validation, stability studies, and the establishment of rigorous impurity profiles.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Betaxolol Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation products in Betaxolol formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product quality.
• Research & Development: Facilitates research into the synthesis pathways, degradation mechanisms, and metabolic profiling of Betaxolol and related compounds.

Basic Information

Product Name	Betaxolol Impurity
CAS No.	131564-70-0
Molecular Formula	C18H31NO3
Molecular Weight	309.45 g/mol
Synonyms	Betaxolol Related Compound; Betaxolol Impurity Standard; 1-[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol Impurity; (RS)-1-[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol; Betaxolol EP Impurity; Betaxolol USP Impurity; Betaxolol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Betaxolol Impurity (CAS 131564-70-0) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, and other critical parameters. We support compliance with ICH guidelines and major pharmacopeial standards.

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 light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under conditions that minimize exposure to ambient light and humidity to maintain long-term stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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