Description

Tolfenamic Acid Impurity CAS NO 1609192-68-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of specific impurities in Tolfenamic Acid drug substances and finished products. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method development, validation, and regulatory compliance for non-steroidal anti-inflammatory drugs (NSAIDs).

Application

• Pharmaceutical Impurity Profiling: Primary use as a certified reference standard for the identification and quantification of specific impurities in Tolfenamic Acid Active Pharmaceutical Ingredients (APIs) and formulations.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Tolfenamic Acid products meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and levels of this impurity over time under various storage conditions, supporting shelf-life determination.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, synthesis by-products, and metabolism of Tolfenamic Acid.

Basic Information

Product Name	Tolfenamic Acid Impurity
CAS No.	1609192-68-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tolfenamic Acid Related Compound; Tolfenamic Acid Specified Impurity; Tolfenamic Acid Degradant; 2-[(3-Chloro-2-methylphenyl)amino]benzoic Acid Impurity; N-(3-Chloro-2-methylphenyl)anthranilic Acid Impurity; Tolfenamic Acid Process Impurity; Tolfenamic Acid EP Impurity; Tolfenamic Acid USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Tolfenamic Acid Impurity CAS 1609192-68-8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, and ISO 17025 guidelines for 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); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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