Description

Cis,trans-(1,1-Dimethylethoxy)Carbonyl Tranexamic Acid-13C2,15N is a stable isotope-labeled derivative of the antifibrinolytic agent tranexamic acid, specifically incorporating carbon-13 and nitrogen-15 isotopes. This compound is critically important as a high-purity internal standard and reference material for quantitative bioanalytical methods, ensuring unparalleled accuracy in pharmacokinetic and metabolic studies. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in the development and validation of LC-MS/MS assays for tranexamic acid.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical, non-interfering reference compound for the precise quantification of tranexamic acid in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic and Bioavailability Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Metabolite Identification and Profiling: Used as a labeled tracer to distinguish drug-derived metabolites from endogenous compounds in mass spectrometry.
• Method Development and Validation: Essential for establishing robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and assay validation for tranexamic acid drug substance and finished dosage forms.
• Forensic and Doping Control Analysis: Provides definitive identification and quantification in specialized testing scenarios requiring high specificity.

Basic Information

Product Name	Cis,trans-(1,1-Dimethylethoxy)Carbonyl Tranexamic Acid-13C2,15N
CAS No.	1346604-84-9
Molecular Formula	C13H2313C215NO4
Molecular Weight	Contact for details
Synonyms	Boc-Tranexamic Acid-13C2,15N; (1,1-Dimethylethyl) (6-((Amino-15N)methyl)-3-((13C)carboxy)cyclohex-3-ene-1-(13C)carboxylate); tert-Butoxycarbonyl Tranexamic Acid-13C2,15N; Boc-TXA-13C2,15N; Isotopically Labeled Tranexamic Acid Derivative; 4-((Amino-15N)methyl)cyclohex-1-ene-1,2-(13C2)dicarboxylic acid 2-tert-butyl ester; Tranexamic Acid Boc-Protected-13C2,15N
EINECS	Contact for details

Quality Control

This high-value analytical standard is manufactured under strict quality controls to ensure isotopic enrichment, chemical purity, and stability. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing isotopic purity (e.g., 13C, 15N atom %), chemical purity by HPLC, and confirmatory spectroscopic data. Our quality system is designed to meet the rigorous demands of GMP/GLP-compliant laboratories.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (13C)	≥ 99 atom % 13C
Isotopic Purity (15N)	≥ 99 atom % 15N
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH limits

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