Description

Bisoprolol Impurity 17 is a designated impurity of the widely used β-blocker pharmaceutical, Bisoprolol. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams to ensure drug purity, safety, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Bisoprolol Impurity 17 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Used in developing and validating sensitive analytical methods, primarily High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing in QA/QC laboratories to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Research and Development: Used in synthetic chemistry research to study the formation pathway of this impurity and develop optimized, impurity-controlled manufacturing processes.

Basic Information

Product Name	Bisoprolol Impurity 17
CAS No.	109791-19-7
Molecular Formula	C18H31NO4
Molecular Weight	325.45 g/mol
Synonyms	1-(4-((2-Isopropoxyethoxy)methyl)phenoxy)-3-((1-methylethyl)amino)-2-propanol; Bisoprolol Related Compound; Bisoprolol EP Impurity; Bisoprolol USP Impurity; 2-Propanol, 1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-; Bisoprolol Process Impurity; Impurity of Bisoprolol Fumarate
EINECS	Contact for details

Quality Control

Every batch of Bisoprolol Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

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. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%

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