Description

Mefenamic Acid Impurity 3 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the non-steroidal anti-inflammatory drug (NSAID) Mefenamic Acid. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Mefenamic Acid active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, and GC methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release Testing: Essential for routine quality control laboratories to confirm the impurity profile of Mefenamic Acid batches meets pharmacopeial (USP, EP) and internal specification limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA, EMA, and others to demonstrate thorough impurity control.
• Research and Development: Used in synthetic chemistry R&D to understand impurity formation pathways and to develop purification processes for the main API.

Basic Information

Product Name	Mefenamic Acid Impurity 3
CAS No.	53877-42-2
Molecular Formula	C15H15NO2
Molecular Weight	241.29 g/mol
Synonyms	2-[(2,3-Dimethylphenyl)amino]benzoic Acid; N-(2,3-Dimethylphenyl)anthranilic Acid; Mefenamic Acid Related Compound C; Mefenamic Acid EP Impurity C; Mefenamic Acid USP Related Compound C; Mefenamic Acid Degradation Product; Ponstel Impurity
EINECS	Contact for details

Quality Control

Every batch of Mefenamic Acid Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. 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 in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	98.0% - 102.0%

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