Description

Bisoprolol Ep Impurity L is a high-purity reference standard used in the pharmaceutical development and quality control of Bisoprolol, a widely prescribed β-blocker. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical laboratories, quality assurance departments, and research institutions involved in the synthesis, validation, and regulatory compliance of cardiovascular medications.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation.
• Critical component in impurity profiling and stability studies for Bisoprolol fumarate active pharmaceutical ingredient (API).
• Used in quality control (QC) testing to monitor and control impurity levels during API manufacturing.
• Essential for regulatory submissions (e.g., to FDA, EMA) to establish impurity specifications.
• Supports research and development (R&D) for process optimization and impurity synthesis pathways.
• Calibration standard for advanced analytical techniques like High-Performance Liquid Chromatography (HPLC) and LC-MS.

Basic Information

Product Name	Bisoprolol Ep Impurity L
CAS No.	1956321-87-1
Molecular Formula	C18H31NO4
Molecular Weight	325.45 g/mol
Synonyms	Bisoprolol Impurity L; Bisoprolol Related Compound L; 1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol Ep Impurity; (RS)-1-(4-((2-(Isopropoxy)ethoxy)methyl)phenoxy)-3-(isopropylamino)propan-2-ol Impurity L; Bisoprolol EP Impurity L; Bisoprolol Process Impurity L; Bisoprolol Fumarate Impurity L
EINECS	Contact for details

Quality Control

Every batch of Bisoprolol Ep Impurity L is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including those referenced in the European Pharmacopoeia (EP). Comprehensive characterization is performed using HPLC, NMR, and MS. Certificates of Analysis (COA) with detailed chromatographic data are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.