Description

Ozagrel Impurity 21 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Ozagrel, an antiplatelet agent. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Ozagrel API and its formulations.
• Quality Control & Assurance (QC/QA): Used for the identification, qualification, and precise quantification of this specific impurity in Ozagrel drug substances and products to meet ICH guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles and control strategies.
• Stability Studies: Employed to monitor the formation and levels of this impurity over time under various stress conditions to establish shelf life.
• Process Chemistry R&D: Aids in the optimization of synthesis and purification processes for Ozagrel by tracking and minimizing this impurity.
• Pharmacopoeial Testing: Supports testing to comply with pharmacopoeial monographs (e.g., USP, EP) that specify impurity limits.

Basic Information

Product Name	Ozagrel Impurity 21
CAS No.	883942-98-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ozagrel Related Compound 21; Ozagrel EP Impurity I; Ozagrel USP Impurity 21; (E)-3-[4-(1H-Imidazol-1-ylmethyl)phenyl]-2-propenoic Acid Impurity; Ozagrel Process Impurity; Antiplatelet Agent Impurity; (E)-3-[p-(Imidazol-1-ylmethyl)phenyl]acrylic Acid Related Substance
EINECS	Contact for details

Quality Control

Every batch of Ozagrel Impurity 21 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopoeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and assigned structure confirmation, is provided with each shipment.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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