Description

Ezetimibe Impurity 55 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 cholesterol-lowering drug Ezetimibe during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments. The use of this well-characterized impurity standard is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Ezetimibe active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control the level of this specific impurity, ensuring product consistency and compliance with ICH guidelines.
• Stability Studies: A key component in forced degradation and long-term stability studies to identify and quantify degradation products of Ezetimibe.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry research to study the formation pathway and chemical behavior of this impurity.

Basic Information

Product Name	Ezetimibe Impurity 55
CAS No.	1368310-60-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 55; Ezetimibe EP Impurity G; Ezetimibe USP Impurity; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-7V3R8N71Q2; Azetidin-2-one derivative of Ezetimibe; Ezetimibe Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 55 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with pharmacopeial standards (USP/EP/ICH). Comprehensive Certificates of Analysis (COA) are provided, detailing results from HPLC, NMR, and MS analyses, along with batch-specific data. We are committed to supplying reference materials that meet the exacting requirements of pharmaceutical quality control and regulatory compliance.

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 must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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