Description

Ezetimibe Impurity 70 is a designated impurity standard used in the analytical profiling and quality control of the cholesterol-lowering drug, Ezetimibe. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations by providing a reference for identifying and quantifying process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of Ezetimibe-based products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ezetimibe Impurity 70 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure drug substance and drug product batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Ezetimibe.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity thresholds and control strategies as per ICH Q3A and Q3B.
• Process Chemistry Research: Aids in understanding and optimizing the Ezetimibe synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Ezetimibe Impurity 70
CAS No.	439113-83-4
Molecular Formula	C24H21F2NO3
Molecular Weight	409.43 g/mol
Synonyms	(3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; Ezetimibe Related Compound 70; Ezetimibe EP Impurity G; Ezetimibe USP Impurity 70; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone; Zetia Impurity 70
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 70 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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