Description

Ondansetron Hydrochloride is a potent and highly selective serotonin 5-HT₃ receptor antagonist. This active pharmaceutical ingredient (API) is critical for the prevention 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.

Application

• Pharmaceutical API: Primary raw material for the synthesis of finished antiemetic drugs.
• Injectable Formulations: Used in the production of intravenous (IV) and intramuscular (IM) solutions for acute nausea control in hospital settings.
• Oral Solid Dosage Forms: Key ingredient in the manufacture of tablets and orally disintegrating tablets (ODTs) for convenient patient administration.
• Chemotherapy-Induced Nausea and Vomiting (CINV): Prophylaxis and treatment of emesis associated with highly emetogenic cancer chemotherapy.
• Postoperative Nausea and Vomiting (PONV): Prevention and management of nausea following surgical procedures.
• Radiotherapy-Induced Nausea: Management of nausea in patients undergoing radiation treatment.

Basic Information

Item	Details
Product Name	Ondansetron Hydrochloride
CAS No.	146475-23-2
Molecular Formula	C18H19N3O·HCl·2H2O
Molecular Weight	365.86 g/mol (dihydrate)
Synonyms	Ondansetron HCl; Ondansetron Hydrochloride Dihydrate; 1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate; Zofran (brand name active ingredient); GR 38032F; SN 307
EINECS	Contact for details

Quality Control

Our Ondansetron Hydrochloride is manufactured under strict quality management systems. We provide material that meets or exceeds relevant pharmacopoeial standards, including USP and EP monographs. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring compliance for GMP manufacturing.

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.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
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)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%

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