Topiramate

Topiramate

Nome del prodotto Topiramate
Numero CAS 97240-79-4
Formula molecolare C12H21NO8S
Peso molecolare 339.36 g/mol
Aspetto Polvere cristallina di colore da bianco a bianco sporco
Analisi (HPLC) 98.0% – 102.0% (on dried basis)
Punto di fusione 125°C – 127°C
Solubilità Sparingly soluble in water; freely soluble in acetone, chloroform, and ethanol
Confezione 25 kg fiber drum with double polyethylene liners

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Topiramate Structure

Sinonimi: 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.

Funzione

  • 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.

Fonte e standardizzazione

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

Caratteristiche tecniche

Parametro Specifiche
Analisi (HPLC) 98.0% – 102.0%
Identificazione IR, HPLC retention time conforms to standard
Perdita per essiccazione ≤ 0,51 TP3T
Residuo di combustione ≤ 0,11 TP3T
Metalli pesanti ≤ 20 ppm
Limiti microbiologici Conta aerobica totale ≤ 1000 UFC/g; lieviti e muffe ≤ 100 UFC/g; assenza di E. coli

Documentazione e forniture

  • Capacità mensile: 10 metric tons
  • Tempi di consegna: 3-5 business days (stock items)
  • Documentazione: COA, MSDS, TDS e documentazione normativa disponibili su richiesta
  • Confezionamento: 25 kg fiber drum with double polyethylene liners, or as per customer requirements

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