Description

Bisoprolol Ep Impurity N is a high-purity reference standard specifically used in the pharmaceutical development and quality control of Bisoprolol, a widely prescribed β-blocker. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a key marker for impurity profiling. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing. The compound is supplied with full analytical characterization to support method validation and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Bisoprolol-related impurities in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor and control impurity levels during API synthesis and final drug product formulation.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and Common Technical Documents (CTD).
• Stability Studies: Employed as a benchmark to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A stability testing guidelines.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this specific impurity during the synthesis of Bisoprolol fumarate.

Basic Information

Product Name	Bisoprolol Ep Impurity N
CAS No.	1346601-75-9
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 N; Bisoprolol Related Compound N; Bisoprolol EP Impurity N; Bisoprolol Fumarate Impurity N; (RS)-1-{4-[(2-Isopropoxyethoxy)methyl]phenoxy}-3-(isopropylamino)propan-2-ol Impurity; Process Impurity of Bisoprolol; Bisoprolol Isomer
EINECS	Contact for details

Quality Control

Every batch of Bisoprolol Ep Impurity N is manufactured and controlled under a strict quality management system. It undergoes comprehensive analytical testing, including HPLC for purity, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data, traceable to primary standards, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent absorption of moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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