Description

Ezetimibe Impurity 109 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the cholesterol-lowering drug Ezetimibe during its development and manufacturing. It serves as a key marker for quality control and regulatory compliance in the pharmaceutical industry. Researchers and quality assurance professionals in pharmaceutical R&D and production rely on this impurity standard for method validation and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ezetimibe active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical manufacturing facilities to ensure product specifications meet pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in Ezetimibe under various stress conditions (heat, light, humidity) as per ICH Q1A(R2).
• Research & Development: Facilitates process chemistry research, helping to understand and control the formation of this impurity during the synthetic pathway of Ezetimibe.

Basic Information

Product Name	Ezetimibe Impurity 109
CAS No.	163222-31-9
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 109; Ezetimibe EP Impurity J; Ezetimibe USP Impurity 109; Ezetimibe Process Impurity; Zetia Impurity 109; SCH 58235 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 109 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ISO 17034, and ISO/IEC 17025 standards for reference material producers.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% 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.