Description

Oxaprozin Impurity 2 is a designated impurity of the non-steroidal anti-inflammatory drug (NSAID) Oxaprozin. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Oxaprozin Impurity 2 in Oxaprozin API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC, UPLC, and GC, to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure the impurity profile of Oxaprozin meets ICH Q3A/B guidelines and pharmacopeia specifications (USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Required for compiling impurity data in regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive control of the drug substance.
• Research and Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Oxaprozin.

Basic Information

Product Name	Oxaprozin Impurity 2
CAS No.	24248-49-5
Molecular Formula	C18H15NO3
Molecular Weight	293.32 g/mol
Synonyms	4,5-Diphenyl-2-oxazolepropionic Acid; Oxaprozin Related Compound; 3-[4,5-Diphenyl-1,3-oxazol-2-yl]propanoic Acid; 2-Oxazolepropionic Acid, 4,5-diphenyl-; Oxaprozin Impurity B; Oxaprozin EP Impurity B; Oxaprozin USP Impurity; 24248-49-5
EINECS	Contact for details

Quality Control

Every batch of Oxaprozin Impurity 2 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality standards align with ICH guidelines and current Good Manufacturing Practices (cGMP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and identification (typically by HPLC, IR, and MS). Specifications are set to meet the requirements of major pharmacopeias.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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