Description

Bisoprolol Ep Impurity C is a specified impurity associated with the active pharmaceutical ingredient Bisoprolol, a widely used β-blocker. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Bisoprolol-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Bisoprolol fumarate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating high-performance liquid chromatography (HPLC), UPLC, or other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure API and drug products meet stringent pharmacopoeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Facilitates studies on the synthesis, degradation pathways, and toxicological profile of Bisoprolol-related compounds.

Basic Information

Product Name	Bisoprolol Ep Impurity C
CAS No.	1797132-90-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bisoprolol Related Compound C; Bisoprolol Impurity C; Bisoprolol EP Impurity C; 1-(4-((2-Isopropoxyethoxy)methyl)phenoxy)-3-((1-methylethyl)amino)-2-propanol Impurity; Bisoprolol Fumarate Impurity C; Bisoprolol Process Impurity; Bisoprolol Degradation Product
EINECS	Contact for details

Quality Control

Our Bisoprolol Ep Impurity C is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, NMR, and mass spectrometry. We adhere to relevant ICH guidelines and support compliance with pharmacopoeial standards (USP, EP).

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 (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under 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)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 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.