Description

Bisoprolol Impurity CAS NO 2226263-67-6 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 quality control testing.

Application

• Primary use as a reference standard for the identification and quantification of impurities in Bisoprolol Fumarate active pharmaceutical ingredient (API) and finished dosage forms.
• Essential for analytical method development and validation (HPLC, LC-MS) in pharmaceutical quality control laboratories.
• Used in stability studies to monitor impurity profiles and degradation pathways of Bisoprolol-based drug products.
• Critical for regulatory compliance and filing, supporting ICH guidelines (Q3A, Q3B) on impurities in new drug substances and products.
• Serves as a research tool in pharmacokinetic and metabolic studies related to Bisoprolol.
• Supports pharmacopoeial testing to meet standards set by USP, EP, and other international compendia.

Basic Information

Product Name	Bisoprolol Impurity
CAS No.	2226263-67-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bisoprolol Related Compound; Bisoprolol Fumarate Impurity; Bisoprolol Process Impurity; Bisoprolol Degradant; (RS)-1-(4-((2-Isopropoxyethoxy)methyl)phenoxy)-3-(isopropylamino)propan-2-ol Impurity; 1-[4-[[2-(Isopropoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol Impurity
EINECS	Contact for details

Quality Control

Our Bisoprolol Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.