Description

Nimesulide Ep Impurity CAS NO 38880-53-4 is a high-purity reference standard used in the analytical development and quality control of the pharmaceutical drug Nimesulide. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory affairs teams focused on method validation and compliance with stringent pharmacopoeial standards like EP, USP, and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Nimesulide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or GC methods as per ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity profiles and ensure every batch of Nimesulide API meets specified purity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) for shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and responses to regulatory agency queries.
• Pharmaceutical Research: Supports research into the synthesis pathways, degradation mechanisms, and metabolic profiling of Nimesulide.

Basic Information

Product Name	Nimesulide Ep Impurity
CAS No.	38880-53-4
Molecular Formula	C13H12N2O5S
Molecular Weight	308.31 g/mol
Synonyms	4-Nitro-2-phenoxymethanesulfonanilide; N-(4-Nitro-2-phenoxyphenyl)methanesulfonamide; 2-Phenoxy-4-nitrobenzenemethanesulfonamide; Nimesulide Impurity; Nimesulide Related Compound; European Pharmacopoeia Nimesulide Impurity
EINECS	Contact for details

Quality Control

Every batch of Nimesulide Ep Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopoeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for appearance, identification (HPLC, IR), assay (HPLC), related substances, residual solvents, and other critical parameters.

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 light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and opened only under controlled conditions to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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