Description

Nepafenac Impurity CAS NO 98790-48-8 is a high-purity reference standard used in the analytical development and quality control of the non-steroidal anti-inflammatory drug (NSAID) Nepafenac. This compound is critical for ensuring the safety and efficacy of the final pharmaceutical product by enabling the accurate identification, quantification, and control of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on research, method validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods (e.g., HPLC, LC-MS) for Nepafenac API and finished dosage forms.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the levels of this specific impurity, ensuring drug product purity meets pharmacopeial (USP, EP, ICH) guidelines.
• Research & Development (R&D): Employed in stability studies, forced degradation studies, and impurity profiling to understand the degradation pathways and stability profile of Nepafenac.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity identification, qualification thresholds, and control strategies.
• Method Development & Validation: A key component in developing, optimizing, and validating chromatographic methods specific to the analysis of Nepafenac and its related substances.

Basic Information

Product Name	Nepafenac Impurity
CAS No.	98790-48-8
Molecular Formula	C15H14N2O2
Molecular Weight	254.28 g/mol
Synonyms	2-Amino-3-benzoyl-N-methylbenzeneacetamide; Nepafenac Related Compound; Nepafenac Degradation Product; Nepafenac Process Impurity; 2-(2-Amino-3-benzoylphenyl)acetamide, N-methyl-; Benzeneacetamide, 2-amino-3-benzoyl-N-methyl-
EINECS	Contact for details

Quality Control

Every batch of Nepafenac Impurity (CAS 98790-48-8) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using validated analytical methods (HPLC, NMR, MS) to ensure compliance with industry and regulatory standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure maximum 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)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
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.