Description

Ezetimibe Impurity 94 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 (QC) units, and regulatory affairs departments. The material is essential for method development, validation, and the accurate quantification of impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Ezetimibe API and formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating stability-indicating chromatographic methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor and control the levels of specified impurities, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions & Compliance: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug product stability testing.
• Research & Process Chemistry: Aids in understanding the synthesis pathway and degradation mechanisms of Ezetimibe, supporting process optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Ezetimibe Impurity 94
CAS No.	2363086-22-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 94; Ezetimibe EP Impurity J; Ezetimibe USP Impurity; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-7F6T461JST; Azetidin-2-one derivative of Ezetimibe; Ezetimibe Degradant
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 94 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, including batch-specific results for identity, assay, and impurity profile. The material is suitable for use in compliance with ICH, USP, and EP guidelines.

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, which could affect stability and purity. For long-term storage, consider desiccants or 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)	≥ 95.0%
Related Substances (HPLC)	Any individual 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.