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Topiramate Structure

PRODUCT TYPE

API

GRADE

Pharmaceutical Grade

CHEMICAL FORMULA

C12H21NO8S

IUPAC NAME

2,3:4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate

CAS NO

97240-79-4

MOLECULAR WEIGHT

339.36 g/mol

CHEMICAL CLASS

Fructopyranose sulfamate derivative

THERAPEUTIC CLASS

Antiepileptic / Migraine prophylactic agent

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance White to off-white crystalline powder
Solubility Slightly soluble in water; freely soluble in acetone, ethanol, and methanol; insoluble in ether
Melting Point 178 – 182°C (with decomposition)
pH (1% aqueous solution) 4.0 – 5.0

Product Description

Topiramate is a sulfamate-substituted monosaccharide derivative with broad-spectrum anticonvulsant and neuromodulatory properties. It is primarily indicated for the treatment of epilepsy and migraine prevention, and is also used in psychiatric and metabolic disorders. Topiramate’s unique mechanism combines voltage-gated sodium channel inhibition, enhancement of GABAergic activity, and inhibition of excitatory glutamate pathways.

How Topiramate Works

Topiramate exhibits a multifactorial mechanism of action that contributes to its antiepileptic and neuroprotective efficacy: (1) blocks voltage-gated sodium channels to stabilize neuronal membranes, (2) enhances inhibitory GABAergic neurotransmission, (3) antagonizes excitatory glutamate (AMPA/kainate) receptors, and (4) weakly inhibits carbonic anhydrase enzymes—collectively reducing neuronal hyperexcitability and seizure propagation.

Use(s)

Adverse Effects

Why choose Salius for Topiramate?

  1. WHO-GMP Certified Manufacturing
    Produced in WHO-GMP, ISO 9001:2015, and FDA-audited facilities with validated purification, drying, and milling processes ensuring high purity and uniform particle size.
  2. Consistent Quality and Reliability
    Each batch undergoes full pharmacopeial testing, including HPLC purity, related substances, residual solvents, and polymorphic control for consistent reproducibility.
  3. Global Export Experience & Documentation Support
    Comprehensive dossiers (DMF/CTD), analytical validation data, and stability studies provided for global regulatory submissions.
  4. Documents We Provide
  5. Regulatory and Technical Expertise
    Regulatory team supports dossier customization and country-specific registration (LATAM, MENA, ASEAN, CIS, and Africa).
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

Topiramate is manufactured in WHO-GMP and FDA-audited facilities in India, ensuring global compliance and consistent batch reproducibility.

Pharmaceutical Grade conforming to USP / BP / IP specifications, with analytical methods validated as per ICH guidelines.

Topiramate is non-hazardous and suitable for air or sea shipment under controlled temperature and humidity to maintain product integrity.

10–15 working days depending on stock, documentation, and shipping arrangements.

Yes. We assist with dossier preparation, CTD/ACTD formatting, and country-specific data customization for faster product registration.

Yes. Fully compliant with ICH Q7, EU-GMP, and USFDA guidelines; supported by validated analytical data and stability studies.

We offer ongoing documentation updates, COA revalidation, technical clarifications, and assistance during regulatory audits.

Place an Order or Request a Quote from Salius Pharma

Looking to source Topiramate or other high-quality pharmaceutical products?
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Whether you need Active Pharmaceutical Ingredients (APIs), finished formulations, or regulatory support, our team is ready to provide dependable, compliant, and cost-effective solutions tailored to your market needs.

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Any patented products are excluded from our offerings in regions where such patents are currently in force.

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