Description

Mirisetron Maleate is a high-purity active pharmaceutical ingredient (API) used in the development of antiemetic medications. This compound is critical for pharmaceutical manufacturers requiring reliable, well-characterized substances for formulation and clinical research. It is primarily utilized by the pharmaceutical industry for the development and production of 5-HT3 receptor antagonist drugs.

Application

• Active Pharmaceutical Ingredient (API) in antiemetic drug formulations.
• Key intermediate in the synthesis of advanced pharmaceutical compounds targeting serotonin receptors.
• Reference standard for analytical method development and quality control in pharmaceutical laboratories.
• Research and development of novel therapeutics for chemotherapy-induced nausea and vomiting (CINV).
• Pre-clinical and clinical trial material for new drug applications (NDA).
• Manufacturing of finished dosage forms such as tablets or injectables under GMP conditions.

Basic Information

Product Name	Mirisetron Maleate
CAS No.	148611-75-0
Molecular Formula	C21H25N3O5
Molecular Weight	399.44 g/mol
Synonyms	Mirisetron maleate; (3aS,4R,7aR)-4,5,6,7-Tetrahydro-4-(1-methyl-1H-imidazol-5-ylmethyl)-2H-isoindole-1,3(3aH,7aH)-dione maleate; YM-114; YM 114; YM114; 1H-Isoindole-1,3(2H,3aH,7aH)-dione, 4,5,6,7-tetrahydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]-, (3aS,4R,7aR)-, (2Z)-2-butenedioate (1:1)
EINECS	Contact for details

Quality Control

Our Mirisetron Maleate is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical development. Certificates of Analysis (COA) are provided with each shipment, detailing comprehensive analytical results from tests including HPLC, IR, and residual solvent analysis.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 1.0%
Specific Rotation	Contact for details

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