Description

Nitisinone-13C6 CAS NO 1246815-63-3 is a stable isotope-labeled analog of the therapeutic agent nitisinone, where six carbon atoms are replaced with the carbon-13 isotope. This compound is critically important as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical researchers, clinical laboratories, and contract research organizations (CROs) engaged in drug development and therapeutic monitoring.

Application

• Quantitative Mass Spectrometry (LC-MS/MS): Serves as a critical internal standard for the precise quantification of nitisinone and its metabolites in biological matrices such as plasma, serum, and urine.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and non-clinical research.
• Therapeutic Drug Monitoring (TDM): Used in clinical laboratories to monitor nitisinone concentrations in patients with hereditary tyrosinemia type 1 (HT-1), ensuring optimal dosing and efficacy.
• Method Development and Validation: A key component in developing and validating robust, regulatory-compliant bioanalytical assays for Good Laboratory Practice (GLP) and clinical trials.
• Metabolite Identification and Profiling: Aids in the structural elucidation and quantification of metabolite formation pathways.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and stability-indicating assays for drug substance and product analysis.

Basic Information

Product Name	Nitisinone-13C6
CAS No.	1246815-63-3
Molecular Formula	C1413C6H10F3NO5
Molecular Weight	~335.2 (for 13C6 labeled form)
Synonyms	2-(2-Nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione-13C6; NTBC-13C6; Orfadin-13C6; 4-Hydroxyphenylpyruvate dioxygenase inhibitor-13C6; 2-(2-Nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione-13C6; Isotopically labeled nitisinone; [13C6]-Nitisinone
EINECS	Contact for details

Quality Control

Our Nitisinone-13C6 is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as chemical purity (by HPLC), isotopic purity (by MS), and residual solvent content. We adhere to relevant industry standards for reference materials, and our quality commitment ensures data integrity for your critical research and regulatory submissions.

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. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	Yellow to light brown crystalline powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0%
Isotopic Purity (13C6)	≥ 99 atom % 13C
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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