Description

Bisoprolol Impurity 9 is a designated impurity standard used in the analytical profiling and quality control of the cardiovascular active pharmaceutical ingredient (API) Bisoprolol. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Bisoprolol Impurity 9 in Bisoprolol Fumarate API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: A critical component in the QC testing of Bisoprolol API to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing impurity characterization data.
• Research & Development: Used in R&D to study the degradation pathways and synthesis process of Bisoprolol.

Basic Information

Product Name	Bisoprolol Impurity 9
CAS No.	59383-52-7
Molecular Formula	C18H31NO4
Molecular Weight	325.45 g/mol
Synonyms	1-(4-{[2-(1-Methylethoxy)ethoxy]methyl}phenoxy)-3-[(1-methylethyl)amino]-2-propanol; Bisoprolol Related Compound B; Bisoprolol EP Impurity B; Bisoprolol USP Related Compound B; 2-Propanol, 1-(4-{[2-(1-methylethoxy)ethoxy]methyl}phenoxy)-3-[(1-methylethyl)amino]-; Bisoprolol Isopropylamine Impurity
EINECS	Contact for details

Quality Control

Our Bisoprolol Impurity 9 is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results against stringent in-house specifications aligned with ICH guidelines. Our commitment to traceability and reliability makes this standard suitable for GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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