Description

Tolfenamic Acid-13C6 is a stable isotope-labeled analog of the non-steroidal anti-inflammatory drug (NSAID) Tolfenamic Acid, where six carbon atoms are replaced with the 13C isotope. This compound is an essential internal standard for the precise quantification and pharmacokinetic studies of Tolfenamic Acid in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug metabolism, bioanalytical method development, and clinical research to ensure data accuracy and regulatory compliance.

Application

• Internal Standard for Quantitative Bioanalysis: Used as a critical reference standard in LC-MS/MS methods for the accurate measurement of Tolfenamic Acid concentrations in plasma, serum, and tissue samples.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Facilitates reliable tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Clinical Research and Therapeutic Drug Monitoring (TDM): Enables precise assay development for monitoring drug levels in patients to optimize dosage and ensure therapeutic efficacy.
• Pharmaceutical Impurity Profiling and Method Validation: Serves as a spike-in standard for validating analytical methods and assessing recovery rates in accordance with ICH guidelines.
• Forensic and Anti-Doping Analysis: Employed in confirmatory testing protocols where high specificity and accuracy are mandated.
• Metabolomics Research: Aids in the identification and quantification of drug-derived metabolites in complex biological systems.

Basic Information

Product Name	Tolfenamic Acid-13C6
CAS No.	1420043-61-3
Molecular Formula	C13C6H12ClNO2
Molecular Weight	~268.7 g/mol (13C6 labeled)
Synonyms	2-[(3-Chloro-2-methylphenyl)amino]-13C6-benzoic Acid; Tolfenamic Acid (13C6); Tolfenamic-13C6 Acid; N-(2-Methyl-3-chlorophenyl)anthranilic-13C6 Acid; 13C6-Labeled Tolfenamic Acid; Tolfenamic Acid (carbon-13C6); CL-583; GEA-6414; Migeon; Migen; Tolfedine; Tolfenamic Acid-13C6 Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Tolfenamic Acid-13C6 is manufactured and analyzed under strict quality management systems to ensure exceptional isotopic purity and chemical identity. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for isotopic enrichment, chemical purity (by HPLC), and identity confirmation (by NMR and MS).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥99 atom % 13C
Chemical Purity (by NMR)	≥98.0%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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