Description

Bisoprolol Ep Impurity J CAS NO 1797024-50-0 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 Fumarate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves 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: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., to FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Stability Studies: Employed as a marker to monitor the formation of degradation products during forced degradation and long-term stability testing of Bisoprolol formulations.
• Research & Development: Used in R&D settings to study the degradation pathways and chemical behavior of Bisoprolol under various conditions.
• Quality Control Testing: Acts as a primary standard in routine QC testing to ensure batch-to-batch consistency and adherence to pharmacopeial specifications (e.g., USP, EP).

Basic Information

Product Name	Bisoprolol Ep Impurity J
CAS No.	1797024-50-0
Molecular Formula	C18H31NO4
Molecular Weight	325.45 g/mol
Synonyms	Bisoprolol Related Compound J; Bisoprolol Impurity J; 1-(4-((2-Isopropoxyethoxy)methyl)phenoxy)-3-((1-methylethyl)amino)-2-propanol Impurity; 2-Propanol, 1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-, (R)-; (R)-1-(4-((2-Isopropoxyethoxy)methyl)phenoxy)-3-(isopropylamino)propan-2-ol; Bisoprolol EP Impurity J; Bisoprolol Fumarate Impurity J
EINECS	Contact for details

Quality Control

Our Bisoprolol Ep Impurity J is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current pharmacopeial standards and ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.