Description

Celiprolol Ep Impurity B is a specified impurity and degradation product of the β-blocker pharmaceutical, Celiprolol. This compound is critical for analytical research and quality control in pharmaceutical development and manufacturing. It is primarily used by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Celiprolol active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurity profiles during stability studies.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays for commercial batches.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Process Chemistry Research: Used by chemists to understand and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Celiprolol Ep Impurity B
CAS No.	125579-40-0
Molecular Formula	C20H31N3O4
Molecular Weight	377.48 g/mol
Synonyms	N-[3-Acetyl-4-[3-[(1,1-Dimethylethyl)amino]-2-hydroxypropoxy]phenyl]butanamide; Celiprolol EP Impurity B; Celiprolol Related Compound B; Celiprolol Impurity B; (RS)-N-[3-Acetyl-4-[3-(tert-butylamino)-2-hydroxypropoxy]phenyl]butyramide; Butanamide, N-[3-acetyl-4-[3-[(1,1-dimethylethyl)amino]-2-hydroxypropoxy]phenyl]-; UNII-2V7Q4F6W0I
EINECS	Contact for details

Quality Control

Every batch of Celiprolol Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided and available upon request to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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