Description

Ezetimibe Impurity CAS NO 1510820-22-0 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the cholesterol-lowering drug Ezetimibe by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly for method validation and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of specific impurities in Ezetimibe Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine QC testing to establish acceptance criteria, ensure batch-to-batch consistency, and maintain the purity specifications of Ezetimibe.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles in Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis, purification, and scale-up of Ezetimibe manufacturing processes.

Basic Information

Product Name	Ezetimibe Impurity
CAS No.	1510820-22-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound; Ezetimibe Specified Impurity; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-9K7K5V6591; 1510820-22-0; Ezetimibe EP Impurity; Ezetimibe USP Impurity
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity is manufactured 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, ensuring it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive; prolonged exposure to light should be avoided to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 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.