Description

Mefenamic Acid Impurity 5 (Mefenamic Acid EP Impurity E) is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products containing mefenamic acid. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in mefenamic acid Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish system suitability, specificity, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., USP, EP, ICH).
• Regulatory Submissions & Compliance: Essential for generating impurity data packages required for Drug Master Files (DMFs), New Drug Applications (NDAs), and regulatory audits.
• Stability Studies: Used to track the formation of degradation products in mefenamic acid formulations under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Facilitates research into the degradation pathways, pharmacokinetics, and toxicological profile of mefenamic acid and related compounds.

Basic Information

Product Name	Mefenamic Acid Impurity 5 (Mefenamic Acid EP Impurity E)
CAS No.	4869-11-8
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 Impurity E; Mefenamic Acid Related Compound E; Mefenamic Acid EP Impurity E; Mefenamic Acid USP Impurity; Mefenamic Acid Degradation Product
EINECS	Contact for details

Quality Control

Our Mefenamic Acid Impurity 5 is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity, ensuring compliance with pharmacopeial guidelines (EP, USP) and ICH Q3A/B requirements. A detailed Certificate of Analysis (COA) is provided with every shipment, containing batch-specific data on purity, impurities, and analytical results.

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity 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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.