Description

Bisoprolol Ep Impurity D CAS NO 1225195-71-0 is a specified impurity of the β-blocker pharmaceutical, Bisoprolol. This compound is critical for pharmaceutical research, development, and quality control, serving as a certified reference standard for analytical method validation and impurity profiling. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Bisoprolol fumarate active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Bisoprolol fumarate API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Essential for impurity profiling and characterization studies to meet ICH Q3A(R2) and Q3B(R2) regulatory guidelines.
• Used in stability studies to monitor degradation pathways and establish shelf-life specifications for cardiovascular drug products.
• Supports pharmaceutical research into the synthesis, metabolism, and degradation chemistry of Bisoprolol.
• Vital for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive control of the drug substance.

Basic Information

Product Name	Bisoprolol Ep Impurity D
CAS No.	1225195-71-0
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 D; Bisoprolol Related Compound D; Bisoprolol Fumarate Impurity D; Bisoprolol EP Impurity D; (RS)-1-{4-[(2-Isopropoxyethoxy)methyl]phenoxy}-3-(isopropylamino)propan-2-ol Impurity D; Bisoprolol Process Impurity D; Bisoprolol Specified Impurity D
EINECS	Contact for details

Quality Control

Every batch of Bisoprolol Ep Impurity D is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity screening using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS, IR) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

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

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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