Description

Ezetimibe Impurity 35 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 active pharmaceutical ingredient (API) Ezetimibe, a medication used to lower cholesterol. It serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and routine quality control testing. The availability of well-characterized impurities like this is fundamental to meeting stringent pharmacopeial requirements for drug substance and product specifications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ezetimibe API and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance: Used in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed to identify and track degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research for process optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Ezetimibe Impurity 35
CAS No.	1650568-82-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 35; Ezetimibe EP Impurity 35; Ezetimibe USP Impurity 35; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; Ezetimibe Impurity J (Potential); Ezetimibe Isomer; Ezetimibe Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 35 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 under inert conditions or in a desiccator after opening to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.