Description

Tropisetron Hydrochloride is a high-purity pharmaceutical active ingredient, a potent and selective 5-HT3 receptor antagonist. Its primary value lies in its critical role in the prevention and treatment of chemotherapy-induced and post-operative nausea and vomiting (CINV and PONV). This compound is essential for manufacturers in the pharmaceutical industry developing injectable and oral antiemetic formulations, ensuring patient comfort and compliance during challenging medical treatments.

Application

• Pharmaceutical Active Ingredient (API): Core component in the manufacture of finished antiemetic drugs.
• Chemotherapy-Induced Nausea and Vomiting (CINV) Prevention: Formulated for administration to patients undergoing emetogenic cancer chemotherapy.
• Post-Operative Nausea and Vomiting (PONV) Management: Used in medications to prevent nausea following surgical procedures.
• Research and Development: Serves as a reference standard and key intermediate in pharmacological studies and new drug development.
• Formulation Development: For creating various dosage forms, including injectables (IV/IM), tablets, and capsules.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for generic and proprietary drug production.

Basic Information

Product Name	Tropisetron Hydrochloride
CAS No.	105826-92-4
Molecular Formula	C17H20N2O2•HCl
Molecular Weight	320.82 g/mol
Synonyms	Navoban (trade name); ICS 205-930; (1αH,3α,5αH)-Tropan-3-yl 1H-indole-3-carboxylate hydrochloride; Tropisetron HCl; 3-Tropanyl-indole-3-carboxylate hydrochloride; Indole-3-carboxylic acid, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, hydrochloride
EINECS	Contact for details

Quality Control

Our Tropisetron Hydrochloride is manufactured under strict quality systems, targeting standards suitable for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identity, purity, and impurity profile verification. A Certificate of Analysis (COA) detailing specific results for assay, related substances, residual solvents, and other pharmacopoeial parameters is provided with every shipment to ensure full traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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