Description

Ondansetron-D3 is a deuterium-labeled analog of the potent antiemetic drug ondansetron, specifically designed for use as an internal standard in quantitative bioanalytical studies. This high-purity reference material is essential for ensuring the accuracy and reliability of mass spectrometry-based assays, particularly in pharmacokinetic and metabolism research. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies requiring precise measurement of ondansetron in complex biological matrices.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the accurate LC-MS/MS quantification of ondansetron in plasma, serum, and other biological fluids.
• Pharmacokinetic Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and pre-clinical trials.
• Metabolite Identification: Aids in distinguishing drug-derived metabolites from endogenous compounds in complex mass spectrometry data.
• Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods compliant with GLP and FDA/EMA guidelines.
• Doping Control & Forensic Analysis: Used in specialized testing to confirm the presence and concentration of ondansetron.
• Quality Control in Manufacturing: Can be utilized in analytical methods for monitoring the quality and consistency of ondansetron active pharmaceutical ingredient (API) and finished drug products.

Basic Information

Item	Details
Product Name	Ondansetron-D3
CAS No.	1132757-82-4
Molecular Formula	C18H16D3N3O
Molecular Weight	294.38 g/mol
Synonyms	1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one-d3; Ondansetron (methyl-d3); Zofran-d3; GR 38032F-d3; 4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-, methyl-d3; Deuterated Ondansetron
EINECS	Contact for details

Quality Control

Our Ondansetron-D3 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical identity, which are critical for reliable analytical results. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from NMR, HPLC, and MS analysis to confirm chemical purity, isotopic enrichment, and absence of unlabeled compound. We support research compliant with GLP and cGMP guidelines.

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 compound is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (deuterium, D3)	≥ 99.0 atom % D
Chemical Purity (by NMR)	Conforms
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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