Description

Ondansetron-13C-D3 is a stable isotope-labeled internal standard of the antiemetic drug Ondansetron, specifically designed for advanced analytical applications. This high-purity compound is essential for ensuring accuracy and reliability in quantitative mass spectrometry, particularly for pharmacokinetic studies and bioanalytical method development. It is a critical material for pharmaceutical research laboratories, contract research organizations (CROs), and manufacturers engaged in drug metabolism and pharmacokinetics (DMPK) research, therapeutic drug monitoring, and regulatory compliance testing.

Application

• Quantitative Bioanalysis: Serves as an internal standard in LC-MS/MS and GC-MS methods for the precise quantification of Ondansetron in biological matrices (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in clinical and preclinical research.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of Ondansetron.
• Method Development and Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and assay verification during the production of Ondansetron API or finished dosage forms.
• Forensic and Clinical Toxicology: Supports accurate measurement of drug levels in forensic analysis or therapeutic drug monitoring programs.

Basic Information

Item	Details
Product Name	Ondansetron-13C-D3
CAS No.	2699607-85-5
Molecular Formula	C18H1613C2D3N3O
Molecular Weight	Contact for details
Synonyms	1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one-13C-D3; Zofran-13C-D3; GR 38032F-13C-D3; Ondansetron (13C,D3); [13C,D3]-Ondansetron; Isotopically Labeled Ondansetron; Ondansetron Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Ondansetron-13C-D3 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, MS, and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of unlabeled compound. Our quality commitment aligns with the standards expected for research use in regulated environments.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C; ≥ 98 atom % D
Chemical Purity	≥ 95%
Unlabeled Ondansetron	≤ 1.0%
Water Content (KF)	≤ 1.0%
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.