Description

Ozagrel Impurity 16 is a designated impurity standard of the antiplatelet agent Ozagrel. This compound is critical for pharmaceutical research and development, serving as a key reference marker for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API). It is primarily required by analytical chemists and quality control laboratories in the pharmaceutical industry for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ozagrel API and finished drug products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance: Critical for establishing specification limits and ensuring batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Ozagrel to minimize impurity formation.

Basic Information

Product Name	Ozagrel Impurity 16
CAS No.	143945-86-2
Molecular Formula	C13H12N2O2
Molecular Weight	228.25 g/mol
Synonyms	Ozagrel Related Compound 16; (E)-3-[4-(1H-Imidazol-1-ylmethyl)phenyl]-2-propenoic Acid; (E)-3-[4-(Imidazol-1-ylmethyl)phenyl]acrylic Acid; trans-3-[p-(Imidazol-1-ylmethyl)phenyl]acrylic Acid; Ozagrel EP Impurity G; Ozagrel Impurity G; Ozagrel Metabolite; Potential degradation product of Ozagrel
EINECS	Contact for details

Quality Control

Every batch of Ozagrel Impurity 16 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) detailing all test results and traceability is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any single impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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