Topiramate

Topiramate

Nazwa produktu Topiramate
Numer CAS 97240-79-4
Wzór cząsteczkowy C12H21NO8S
Masa cząsteczkowa 339.36 g/mol
Wygląd Biały lub prawie biały krystaliczny proszek
Oznaczenie (HPLC) 98.0% – 102.0% (on dried basis)
Temperatura topnienia 125°C – 127°C
Rozpuszczalność Sparingly soluble in water; freely soluble in acetone, chloroform, and ethanol
Opakowanie 25 kg fiber drum with double polyethylene liners

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Topiramate Structure

Synonimy: 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.

Funkcja

  • 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

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

Dane techniczne

Parametr Specyfikacja
Oznaczenie (HPLC) 98.0% – 102.0%
Identyfikacja IR, HPLC retention time conforms to standard
Strata przy suszeniu ≤ 0,5%
Popiół po spaleniu ≤ 0,11 TP3T
Metale ciężkie ≤ 20 ppm
Wartości graniczne dla mikroorganizmów Total aerobic count ≤ 1000 CFU/g; yeast & mold ≤ 100 CFU/g; E. coli absent

Documentation & Supply

  • Miesięczna wydajność: 10 metric tons
  • Czas realizacji: 3–5 dni roboczych (towary dostępne w magazynie)
  • Dokumentacja: COA, MSDS, TDS, and regulatory support available upon request
  • Opakowanie: 25 kg fiber drum with double polyethylene liners, or as per customer requirements

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