Description

Bisoprolol Impurity CAS NO 2226263-68-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the cardiovascular drug Bisoprolol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Bisoprolol Fumarate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of the drug substance.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Used to identify and track degradation products formed during forced degradation and long-term stability studies of Bisoprolol formulations.
• Research & Development: Supports research into the synthesis, metabolism, and degradation pathways of Bisoprolol and related compounds.

Basic Information

Product Name	Bisoprolol Impurity
CAS No.	2226263-68-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bisoprolol Related Compound; Bisoprolol Fumarate Impurity; Bisoprolol Process Impurity; Bisoprolol Degradant; 1-(4-((2-Isopropoxyethoxy)methyl)phenoxy)-3-((1-methylethyl)amino)-2-propanol Impurity; (RS)-1-{4-[(2-Isopropoxyethoxy)methyl]phenoxy}-3-(isopropylamino)propan-2-ol Impurity
EINECS	Contact for details

Quality Control

Our Bisoprolol Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and traceability. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting compliance with ICH guidelines and current Good Manufacturing Practices (cGMP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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