Topiramate

Topiramate

Produktname Topiramate
CAS-Nummer 97240-79-4
Molekülformel C12H21NO8S
Molekulargewicht 339.36 g/mol
Aussehen Weißes bis cremefarbenes kristallines Pulver
Analyse (HPLC) 98.0% – 102.0% (on dried basis)
Schmelzpunkt 125°C – 127°C
Löslichkeit Sparingly soluble in water; freely soluble in acetone, chloroform, and ethanol
Verpackung 25 kg fiber drum with double polyethylene liners

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Topiramate Structure

Synonyme: Topiramate, 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate, McN-4853, RWJ-17021, TPM

Topiramate is a sulfamate-substituted monosaccharide that has become a staple in the antiepileptic and migraine-prophylaxis markets. Unlike many older anticonvulsants, it was designed from the ground up—born from a deliberate search for compounds that could block seizure spread through multiple mechanisms. First approved in the mid-1990s, it has since earned a place in formularies worldwide, both as monotherapy and as an adjunct for partial-onset seizures, and later for preventing migraines in adults.

Its chemical structure is built on a fructose scaffold, with a sulfamate group that sets it apart from other anticonvulsants. This unique architecture allows topiramate to act on several targets: voltage-gated sodium channels, GABA-A receptors, and AMPA/kainate glutamate receptors. That multi-pronged action is rare among neurological APIs and explains why it remains a focus for researchers exploring broader neurological applications.

For formulators, topiramate is a well-behaved crystalline solid, readily processed into tablets and sprinkle capsules. Its stability profile and compatibility with common excipients make it a reliable choice for both generic and branded products. While it is not a first-line treatment for every patient, its broad efficacy keeps demand steady across North America, Europe, and Asia.

Funktion

  • Anticonvulsant activity: Blocks voltage-gated sodium channels and enhances GABA-mediated inhibition, reducing seizure frequency.
  • Migraine prophylaxis: Modulates cortical spreading depression and glutamatergic transmission, lowering migraine attack frequency.
  • Glutamate antagonism: Inhibits AMPA and kainate receptors, dampening excitatory neurotransmission.
  • Carbonic anhydrase inhibition: Weakly inhibits carbonic anhydrase, contributing to its metabolic effects and side‑effect profile.

Source & Standardization

  • Quelle: Synthetic chemical synthesis
  • Standardization: USP/EP/BP compliant; assay 98.0%–102.0% (HPLC)
  • Forms: White to off-white crystalline powder
  • Anwendungen: Epilepsy, migraine prophylaxis, and investigational uses in neurology and psychiatry

Technische Daten

Parameter Technische Daten
Analyse (HPLC) 98.0% – 102.0%
Identification IR, HPLC retention time conforms to standard
Trocknungsverlust ≤ 0,5%
Verbrennungsrückstand ≤ 0.1%
Schwermetalle ≤ 20 ppm
Microbial Limits Total aerobic count ≤ 1000 CFU/g; yeast & mold ≤ 100 CFU/g; E. coli absent

Documentation & Supply

  • Monthly capacity: 10 metric tons
  • Lieferzeit: 3–5 Werktage (Lagerware)
  • Dokumentation: COA, MSDS, TDS, and regulatory support available upon request
  • Verpackung: 25 kg fiber drum with double polyethylene liners, or as per customer requirements

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