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Pharmaceutical Chemistry
Ondansetron Hydrochloride Dihydrate
Ondansetron hydrochloride dihydrate is a highly effective, selective serotonin receptor antagonist. It serves as a key active pharmaceutical ingredient (API) in the manufacture of antiemetic medications. Its mechanism of action is based on blocking receptors in both the central nervous system (chemoreceptor trigger zone) and the peripheral nervous system. This substance is indispensable in oncological practice for preventing and suppressing nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, as well as in surgery for the prevention of postoperative nausea and vomiting (PONV).
Applications
Production of Sterile Solutions: Used as the primary component for manufacturing injectable formulations (ampoules and vials) for emergency medicine and inpatient care.
Production of Solid Dosage Forms: Applied in tableting processes, including conventional oral tablets and orally disintegrating tablets (ODTs).
Oncology and Radiology: Prevention and management of nausea and vomiting syndromes associated with high, moderate, and low emetogenic chemotherapy and radiation therapy.
Postoperative Period: Prevention and treatment of nausea and vomiting during the early and late periods following surgical interventions under general anesthesia.
Key Advantages
High Selectivity: Target-blocks exclusively receptors without causing extrapyramidal disorders or sedative side effects typical of other neuroleptics.
Rapid Onset and Efficacy: Provides powerful control over the emetic reflex at both central and peripheral levels, significantly improving patients' quality of life.
GMP Compliance: The substance is manufactured in strict accordance with international GMP quality standards, guaranteeing high chemical purity and stability.
Processing Versatility: The physical and chemical properties of the powder allow it to be seamlessly integrated into various manufacturing processes—from direct compression to solution formulation.
Storage & Transportation
- Store in a dry, dark place out of reach of children, in the tightly closed original packaging.
- Recommended storage temperature: do not exceed 25 °C.
- Avoid mechanical damage to the container, protect from moisture, and shield from direct sunlight.
- Transportation is permitted by all modes of covered transport in accordance with the freight regulations applicable to each type of transport. The product belongs to pharmaceutical substances and requires appropriate handling precautions.
Technical Specifications
Appearance
White or almost white crystalline powder
CAS Number
103639-04-9
Molecular Mass
393.9 {g/mol}
Solubility
Sparingly soluble in water and alcohol, freely soluble in methanol
Assay (Purity)
≥ 99.0% (on the anhydrous basis)
Melting Point
177 - 180 ^C}
pH (1% aqueous solution)
3.5 - 5.5
Supply info
- Sealed double polyethylene bags placed inside fiber drums (cardboard drums) containing 25 kg (standard industrial packaging).
- Customized smaller packaging is available upon request for laboratory evaluation or pilot-scale batches (1 kg, 5 kg).