Description

Ondansetron Hydrochloride is a highly selective serotonin 5-HT₃ receptor antagonist, widely recognized for its critical role in preventing chemotherapy-induced and postoperative nausea and vomiting. Its efficacy and safety profile have made it a cornerstone active pharmaceutical ingredient (API) in antiemetic formulations. This compound is essential for pharmaceutical manufacturers developing injectable solutions, oral tablets, and orally disintegrating films to meet global healthcare demands.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription antiemetic medications.
• Oncology Supportive Care: Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin-based regimens.
• Postoperative Recovery: Management and prevention of nausea and vomiting following surgical procedures.
• Radiotherapy-Induced Nausea: Used in protocols to control emesis caused by total body irradiation or radiotherapy targeting the abdomen.
• Formulation Development: Serves as a key component in the R&D of novel drug delivery systems, such as transdermal patches and sustained-release formulations.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of branded ondansetron products.
• Veterinary Medicine: Application in veterinary oncology and post-operative care for animals.

Basic Information

Product Name	Ondansetron Hydrochloride
CAS No.	103639-04-9
Molecular Formula	C18H19N3O·HCl
Molecular Weight	365.87 g/mol (as hydrochloride salt)
Synonyms	Ondansetron HCl; 1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one hydrochloride; GR 38032F; Zofran (brand name active ingredient); (±)-Ondansetron hydrochloride; 4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-, monohydrochloride
EINECS	Contact for details

Quality Control

Our Ondansetron Hydrochloride is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards including USP, EP, and JP. Every batch undergoes comprehensive analytical testing to ensure identity, potency, purity, and safety. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, heavy metals, and microbiological limits is provided with each shipment to guarantee traceability and regulatory readiness.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The container should be kept tightly sealed in a cool, dry, and well-ventilated area, away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbiological Enumeration	Total aerobic microbial count: NMT 1000 cfu/g Total combined yeasts/molds: NMT 100 cfu/g

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