Description

Ozagrel Impurity CAS NO 50363-84-3 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the quality control and analytical validation of Ozagrel, an antiplatelet agent, ensuring the safety and efficacy of the final drug product. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, impurity profiling, and stability studies. The availability of this well-characterized impurity standard is fundamental to meeting stringent global regulatory requirements for drug substance purity.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying related substances in Ozagrel Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a system suitability standard to develop, optimize, and validate HPLC, UPLC, or GC methods for Ozagrel analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Acts as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate comprehensive impurity control.
• Research and Development: Utilized in synthetic chemistry R&D to understand degradation pathways and optimize the manufacturing process of Ozagrel to minimize impurity formation.

Basic Information

Product Name	Ozagrel Impurity
CAS No.	50363-84-3
Molecular Formula	C13H12N2O2
Molecular Weight	228.25 g/mol
Synonyms	(E)-3-[4-(1H-Imidazol-1-ylmethyl)phenyl]-2-propenoic Acid; (E)-3-[4-(Imidazol-1-ylmethyl)phenyl]acrylic Acid; Ozagrel Related Compound; Ozagrel EP Impurity; Ozagrel USP Impurity; trans-3-[p-(1H-Imidazol-1-ylmethyl)phenyl]acrylic Acid; OKY-046 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ozagrel Impurity (CAS 50363-84-3) 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 pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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