Description

Ozagrel Impurity 7 is a designated impurity reference standard used in the analytical profiling and quality control of the pharmaceutical agent Ozagrel. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily utilized by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Ozagrel Impurity 7 in Ozagrel API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QA/QC testing to ensure drug substance and product batches meet stringent pharmacopeial (e.g., USP, EP) or internal specification limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to satisfy health authority requirements.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes by identifying and controlling the formation of this impurity.

Basic Information

Product Name	Ozagrel Impurity 7
CAS No.	883903-91-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ozagrel Related Compound 7; Ozagrel EP Impurity G; Ozagrel USP Impurity; (E)-3-[4-(1H-Imidazol-1-ylmethyl)phenyl]-2-propenoic Acid Impurity; Ozagrel Degradation Product; Ozagrel Process Impurity; Antiplatelet Agent Impurity
EINECS	Contact for details

Quality Control

Every batch of Ozagrel Impurity 7 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure they meet the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results from advanced analytical techniques. We support compliance with cGMP, ICH Q3A/B, and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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