Description

Nepafenac Impurity CAS NO 1881270-49-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Nepafenac, a nonsteroidal anti-inflammatory drug (NSAID). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Nepafenac API and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, and other chromatographic methods for Nepafenac analysis.
• Quality Control and Assurance (QC/QA): Essential for in-process testing and release testing of Nepafenac batches to ensure they meet pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies: Employed to monitor the formation of degradation products in Nepafenac formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research and Development: Used in synthetic chemistry and pharmacology research to study the metabolism, degradation pathways, and structure-activity relationships of Nepafenac.

Basic Information

Item	Detail
Product Name	Nepafenac Impurity
CAS No.	1881270-49-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nepafenac Related Compound; Nepafenac Impurity Standard; 2-Amino-3-benzoyl-N-(2-hydroxyethyl)benzamide Impurity; Nepafenac Degradation Product; Nepafenac Process Impurity; Nepafenac Analytical Reference Standard; Benzamide, 2-amino-3-benzoyl-N-(2-hydroxyethyl)- (related substance)
EINECS	Contact for details

Quality Control

Every batch of Nepafenac Impurity CAS NO 1881270-49-0 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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