Description

Betaxolol Impurity CAS NO 131564-69-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Betaxolol, a widely used β-blocker medication. It serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and regulatory compliance. The impurity is vital for impurity profiling, stability studies, and batch release testing in accordance with stringent pharmacopeial guidelines.

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: Used in developing and validating HPLC, UPLC, and GC methods for impurity profiling and assay determination.
• Quality Control & Assurance: Critical for routine QC testing in pharmaceutical manufacturing to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity formation over time.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and synthesis of Betaxolol and related compounds.

Basic Information

Product Name	Betaxolol Impurity
CAS No.	131564-69-7
Molecular Formula	C18H31NO4
Molecular Weight	325.45 g/mol
Synonyms	1-[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol Related Compound; Betaxolol Related Substance; Betaxolol EP Impurity; Betaxolol USP Impurity; (RS)-1-[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)propan-2-ol; Betaxolol Process Impurity; Betaxolol Degradant
EINECS	Contact for details

Quality Control

Every batch of Betaxolol Impurity (CAS 131564-69-7) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to in-house specifications and relevant pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP requirements for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect from moisture absorption. For long-term storage, consider storing under inert atmosphere.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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