Description

Ezetimibe Impurity 87 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The precise characterization of this impurity is essential for maintaining the stringent quality standards demanded in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Ezetimibe API and finished dosage forms.
• Impurity Profiling and Identification: Essential for identifying and quantifying Ezetimibe Impurity 87 during stability studies and routine quality control testing.
• Method Development and Validation: Serves as a critical component in developing and validating analytical methods, including HPLC, UPLC, and LC-MS, to meet ICH guidelines.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and Common Technical Documents (CTDs).
• Research and Development: Utilized in R&D laboratories to study the degradation pathways and formation mechanisms of impurities in Ezetimibe.
• Quality Assurance/Quality Control (QA/QC): Employed as a system suitability standard and for calibrating equipment to ensure accurate and reliable analytical results in QC laboratories.

Basic Information

Item	Details
Product Name	Ezetimibe Impurity 87
CAS No.	1197343-07-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; Ezetimibe Related Compound 87; Ezetimibe EP Impurity G; Ezetimibe USP Related Compound; Ezetimibe Degradation Product; Ezetimibe Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 87 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, 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). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. The storage area should be well-ventilated and away from incompatible materials.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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