Description

Topiramate is a high-purity sulfamate-substituted monosaccharide derivative, widely recognized as a critical active pharmaceutical ingredient (API). Its primary commercial value lies in its potent and selective activity as an anticonvulsant and neurostabilizing agent. This compound is essential for manufacturers in the global pharmaceutical industry, specifically for the formulation of antiepileptic medications and treatments for related neurological conditions. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final drug products.

Application

• Primary Pharmaceutical Ingredient: Core active component in the manufacture of antiepileptic drugs for the treatment of partial-onset and generalized tonic-clonic seizures.
• Migraine Prophylaxis: Used in the formulation of medications for the prevention of chronic and episodic migraines.
• Neurological Disorder Research: Serves as a key reference standard and intermediate in preclinical and clinical research for various CNS-related disorders.
• Generic Drug Production: Critical for API suppliers serving the generic pharmaceutical market following patent expirations.
• Dosage Form Development: Utilized in the R&D and production of various dosage forms, including tablets, capsules, and sprinkle formulations.
• Combination Therapies: Employed in the development of fixed-dose combination drugs for enhanced therapeutic outcomes.

Basic Information

Product Name	Topiramate
CAS No.	97240-79-4
Molecular Formula	C12H21NO8S
Molecular Weight	339.36 g/mol
Synonyms	Topiramate; 2,3:4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate; Topamax (Trade Name); TPM; McN-4853; RWJ-17021; Antiepileptic Topiramate
EINECS	Contact for details

Quality Control

Our Topiramate is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure it meets stringent purity requirements. A Certificate of Analysis (COA) documenting compliance with relevant in-house or pharmacopeial standards (such as USP/EP) is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (typically 15-25°C). The product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.15% Total impurities: NMT 0.5%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 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.