Description

Ondansetron 8-D-Glucuronide (Mixture Of Isomers) is a key glucuronide metabolite of the antiemetic drug ondansetron. This compound is of significant value in pharmaceutical research and development, particularly for metabolism and pharmacokinetic studies. It is primarily required by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in bioanalytical method development, drug metabolism and pharmacokinetics (DMPK), and impurity reference standard qualification.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of ondansetron metabolites in biological matrices.
• Drug Metabolism Studies (DMPK): Critical for investigating the metabolic pathways, bioavailability, and excretion profiles of ondansetron in preclinical and clinical research.
• Bioanalytical Method Development: Used as a standard for developing and validating sensitive HPLC-MS/MS or LC-MS methods for therapeutic drug monitoring (TDM) and pharmacokinetic assays.
• Impurity Profiling: Employed in the identification and quantification of process-related or degradation impurities in ondansetron drug substance and finished product formulations.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for a major human metabolite.
• Clinical Research: Aids in correlating metabolite levels with drug efficacy and safety profiles during clinical trials.

Basic Information

Product Name	Ondansetron 8-D-Glucuronide (Mixture Of Isomers)
CAS No.	126671-72-5
Molecular Formula	C₂₄H₃₂N₄O₉
Molecular Weight	520.54 g/mol
Synonyms	Ondansetron 8-D-Glucuronide; Ondansetron Glucuronide; 1,2,3,4-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one 8-D-Glucopyranosiduronic Acid; GR 38032F Glucuronide; Zofran Glucuronide; 126671-72-5; UNII-8V5Q8Q8V8F
EINECS	Contact for details

Quality Control

Our Ondansetron 8-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, LC-MS identification, and NMR confirmation, to ensure identity, potency, and purity meet exacting standards for research use. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥95.0% (Area %)
Water Content (KF)	≤5.0%
Isomer Ratio	Specified on COA

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