Description

Betaxolol Ep Impurity E is a high-purity chemical reference standard specifically identified as an impurity of Betaxolol, a β-blocker medication. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities during drug substance manufacturing and quality assurance. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting compliance with stringent regulatory guidelines for drug purity and safety.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Betaxolol-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) used in impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of degradation impurities in Betaxolol under various stress conditions (e.g., heat, light, humidity).
• Pharmacopoeial Testing: Aids in testing to meet the purity requirements specified in pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).

Basic Information

Product Name	Betaxolol Ep Impurity E
CAS No.	1329613-85-5
Molecular Formula	C18H31NO3
Molecular Weight	309.45 g/mol
Synonyms	Betaxolol Impurity E; Betaxolol Related Compound E; 1-[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol Impurity E; (RS)-1-(4-(2-(Cyclopropylmethoxy)ethyl)phenoxy)-3-(isopropylamino)propan-2-ol Impurity E; Betaxolol EP Impurity E; Betaxolol European Pharmacopoeia Impurity E
EINECS	Contact for details

Quality Control

Every batch of Betaxolol Ep Impurity E is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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 single unknown impurity ≤ 0.5%
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.