Description

Ondansetron Hydrochloride CAS NO 99614-01-4 is a potent and selective serotonin 5-HT₃ receptor antagonist. This active pharmaceutical ingredient (API) is critical for the prevention and treatment of nausea and vomiting induced by chemotherapy, radiotherapy, and postoperative conditions. It is an essential raw material for pharmaceutical manufacturers producing antiemetic formulations, including injectables, oral tablets, and orally disintegrating tablets. Our supply ensures high purity and reliable consistency for critical drug production processes.

Application

• Primary Active Pharmaceutical Ingredient (API) in antiemetic drug formulations.
• Manufacturing of injectable solutions for chemotherapy-induced nausea and vomiting (CINV).
• Production of oral solid dosage forms, including standard and orally disintegrating tablets (ODTs).
• Key component in generic pharmaceutical development and production.
• Used in clinical research and reference standard preparation.
• Formulation of prescription medications for postoperative nausea and vomiting (PONV).

Basic Information

Product Name	Ondansetron Hydrochloride
CAS No.	99614-01-4
Molecular Formula	C18H19N3O·HCl·2H2O
Molecular Weight	365.86 g/mol (Dihydrate)
Synonyms	Ondansetron HCl; 1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one hydrochloride dihydrate; GR 38032F; Zofran (brand name); SN 307; (±)-Ondansetron hydrochloride dihydrate; 4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-, hydrochloride, dihydrate
EINECS	Contact for details

Quality Control

Our Ondansetron Hydrochloride is manufactured under strict quality management systems. We provide material compliant with major pharmacopoeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting full compliance with specifications is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	8.0% - 10.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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