Description

Tegaserod Maleate is a selective serotonin 5-HT4 receptor partial agonist, primarily used as a pharmaceutical active ingredient. This compound is critical for the formulation of medications targeting specific gastrointestinal motility disorders. It is essential for pharmaceutical manufacturers and research institutions developing treatments for conditions like irritable bowel syndrome with constipation (IBS-C).

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of prescription drugs for gastrointestinal disorders.
• Research & Development: Used in preclinical and clinical studies to investigate serotonin receptor pharmacology and new therapeutic applications.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.
• Drug Product Manufacturing: Incorporated into final dosage forms such as tablets under current Good Manufacturing Practice (cGMP) conditions.

Basic Information

Product Name	Tegaserod Maleate
CAS No.	189188-57-6
Molecular Formula	C23H30N6O4 • C4H4O4
Molecular Weight	562.59 g/mol
Synonyms	Tegaserod hydrogen maleate; Tegaserod maleate salt; HTF 919; Zelnorm (brand name); 3-(5-Methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide dimaleate; 2-[[(5-Methoxy-1H-indol-3-yl)methylene]amino]-N-pentylhydrazinecarboximidamide (Z)-2-butenedioate (1:1); SDZ HTF 919
EINECS	Contact for details

Quality Control

Our Tegaserod Maleate is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols align with ICH guidelines, and comprehensive testing includes identity, purity, and impurity profile analysis. A Certificate of Analysis (COA) is provided with each batch, detailing specifications for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to humidity.

Specification

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

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