Description

Nepafenac Impurity 5 CAS NO 1246956-18-2 is a high-purity reference standard used for analytical and research purposes in pharmaceutical development. This compound is critical for ensuring the quality, safety, and regulatory compliance of the non-steroidal anti-inflammatory drug (NSAID) Nepafenac. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining the highest standards in drug manufacturing and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nepafenac Impurity 5 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing to ensure drug substance and drug product purity meets pharmacopeial specifications (e.g., USP, ICH Q3A/B).
• Stability Studies: Used to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Supports synthetic route optimization and degradation pathway studies during the drug development process.

Basic Information

Product Name	Nepafenac Impurity 5
CAS No.	1246956-18-2
Molecular Formula	C15H13NO3
Molecular Weight	255.27 g/mol
Synonyms	2-Amino-3-benzoyl-N-(2-hydroxyethyl)benzamide; Nepafenac Related Compound 5; Nepafenac EP Impurity E; Nepafenac USP Impurity; Nepafenac Degradation Product; 2-Amino-3-benzoyl-N-(2-hydroxyethyl)-benzamide; Benzamide, 2-amino-3-benzoyl-N-(2-hydroxyethyl)-
EINECS	Contact for details

Quality Control

Every batch of Nepafenac Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity, related substances, residual solvents, and other critical parameters as per ICH guidelines.

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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.