Topiramate
| Nom du produit | Topiramate |
|---|---|
| Numéro CAS | 97240-79-4 |
| Formule moléculaire | C12H21NO8S |
| Poids moléculaire | 339.36 g/mol |
| Apparence | Poudre cristalline blanche à blanc cassé |
| Essai (HPLC) | 98.0% – 102.0% (on dried basis) |
| Point de fusion | 125°C – 127°C |
| Solubilité | Sparingly soluble in water; freely soluble in acetone, chloroform, and ethanol |
| Colis | 25 kg fiber drum with double polyethylene liners |
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Synonymes : 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.
| Paramètre | Spécifications |
|---|---|
| Essai (HPLC) | 98.0% – 102.0% |
| Identification | IR, HPLC retention time conforms to standard |
| Perte au séchage | ≤ 0,5% |
| Résidu au feu | ≤ 0,11 TP3T |
| Métaux lourds | ≤ 20 ppm |
| Limites microbiologiques | Nombre total de bactéries aérobies ≤ 1 000 UFC/g ; levures et moisissures ≤ 100 UFC/g ; absence d'E. coli |
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