Description

Bisoprolol Ep Impurity F is a specified impurity and degradation product of the widely prescribed β-blocker, Bisoprolol. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Bisoprolol fumarate active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a high-purity certified reference material (CRM) for qualitative and quantitative analysis.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor and control impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Bisoprolol API and formulations to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Bisoprolol Ep Impurity F
CAS No.	1798418-82-2
Molecular Formula	C18H31NO4
Molecular Weight	325.45 g/mol
Synonyms	1-(4-{[2-(1-Methylethoxy)ethoxy]methyl}phenoxy)-3-[(1-methylethyl)amino]-2-propanol Impurity F; Bisoprolol Related Compound F; Bisoprolol Fumarate Impurity F; (RS)-1-{4-[(2-Isopropoxyethoxy)methyl]phenoxy}-3-(isopropylamino)propan-2-ol Impurity F; Bisoprolol EP Impurity F; Bisoprolol USP Impurity F
EINECS	Contact for details

Quality Control

Every batch of Bisoprolol Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 should be handled in a dry environment to prevent degradation.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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