Description

Ondansetron CAS NO 99614-02-5 is a highly selective serotonin 5-HT₃ receptor antagonist, recognized as a critical active pharmaceutical ingredient (API). Its primary value lies in its potent antiemetic properties, effectively preventing nausea and vomiting associated with chemotherapy, radiotherapy, and post-operative recovery. This makes it an essential component for pharmaceutical manufacturers developing injectable solutions, oral tablets, and orally disintegrating films. Global demand is driven by its established efficacy and safety profile in supportive cancer care and surgical settings.

Application

• Pharmaceutical API: Primary use in the formulation of antiemetic medications for chemotherapy-induced nausea and vomiting (CINV).
• Oncology Supportive Care: A key drug in regimens to manage side effects from highly emetogenic cancer treatments.
• Postoperative Nausea and Vomiting (PONV) Prevention: Used in anesthetic and surgical recovery protocols.
• Radiotherapy-Induced Nausea: Administration to patients undergoing radiation therapy.
• Oral Solid Dosage Forms: Manufacture of standard and orally disintegrating tablets (ODTs).
• Parenteral Formulations: Production of sterile injectable solutions and ready-to-use IV bags.
• Research & Development: Reference standard and building block for novel therapeutic agents targeting the 5-HT₃ pathway.

Basic Information

Product Name	Ondansetron
CAS No.	99614-02-5
Molecular Formula	C₁₈H₁₉N₃O
Molecular Weight	293.37 g/mol
Synonyms	Ondansetron Hydrochloride Dihydrate (common salt form); GR 38032F; Zofran® (brand name); 1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one; (±)-1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one; 4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-; NSC-741939
EINECS	Contact for details

Quality Control

Our Ondansetron API is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards including USP, EP, and JP. Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, identification by IR and NMR, and tests for residual solvents, heavy metals, and microbial limits. A Certificate of Analysis (COA) documenting full compliance with agreed specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation. For long-term storage, consider the use of desiccants.

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)	≤ 8.5% (for dihydrate form)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%
Microbial Enumeration	Complies with EP/USP criteria

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