Description

n-Desmethylondansetron is a key pharmaceutical intermediate and metabolite of the antiemetic drug ondansetron. This compound is of significant importance for research, development, and quality control within the pharmaceutical industry. It is primarily utilized by manufacturers and research institutions involved in the synthesis of active pharmaceutical ingredients (APIs), metabolite studies, and analytical method development.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and process development of ondansetron and related 5-HT₃ receptor antagonist drugs.
• Reference Standard: Serves as a high-purity standard for analytical testing, including HPLC, LC-MS, and GC-MS, to ensure drug purity and compliance.
• Metabolite Research: Used in pharmacokinetic and pharmacodynamic studies to understand the metabolism, efficacy, and safety profile of ondansetron.
• Impurity Profiling: Essential for identifying and quantifying process-related impurities in ondansetron API batches to meet ICH guidelines.
• Bioanalytical Method Development: Employed in developing and validating assays for detecting ondansetron and its metabolites in biological matrices.
• Chemical Research: Used as a building block in medicinal chemistry for creating novel derivatives with potential therapeutic applications.

Basic Information

Product Name	n-Desmethylondansetron
CAS No.	99614-14-9
Molecular Formula	C₁₇H₁₈N₄O
Molecular Weight	294.35 g/mol
Synonyms	1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one; Ondansetron Impurity D; Ondansetron Metabolite; Desmethyl Ondansetron; Norondansetron; GR 38032F Metabolite; 4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-
EINECS	Contact for details

Quality Control

Our n-Desmethylondansetron is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of related substances and residual solvents to ensure it meets high-grade standards suitable for pharmaceutical research and development. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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