Frovatriptan Succinate API is the succinate salt of frovatriptan, a selective serotonin 5-HT₁B/5-HT₁D receptor agonist belonging to the triptan class of antimigraine medicines. It is used as an active pharmaceutical ingredient in formulations intended for the acute treatment of migraine attacks.
Frovatriptan Succinate is chemically designated as R-(+)-3-methylamino-6-carboxamido-1,2,3,4-tetrahydrocarbazole monosuccinate monohydrate. The pharmaceutical substance is supplied as the monohydrate and has the molecular formula C₁₄H₁₇N₃O·C₄H₆O₄·H₂O, commonly represented as C₁₈H₂₅N₃O₆, with a molecular weight of 379.41 g/mol. FDA's substance record confirms the formula, stereochemistry and molecular weight.
Frovatriptan Succinate is described as a white to off-white powder, soluble in water and very slightly soluble in methanol.
| Property | Value |
|---|---|
| API Name | Frovatriptan Succinate |
| CAS Number | 158930-17-7 |
| Molecular Formula | C₁₄H₁₇N₃O·C₄H₆O₄·H₂O |
| Molecular Weight | 379.41 g/mol |
| Salt Form | Succinate monohydrate |
| Chemical Class | Triptan / 5-HT₁B/5-HT₁D agonist |
| Stereochemistry | R-(+) |
| Appearance | White to off-white powder |
| Water Solubility | Soluble in water |
| Methanol Solubility | Very slightly soluble in methanol |
The CAS number 158930-17-7 specifically corresponds to Frovatriptan Succinate Monohydrate.
Frovatriptan acts primarily as an agonist at 5-HT₁B and 5-HT₁D serotonin receptors. Activation of these receptors on cranial blood vessels and trigeminal sensory pathways produces vasoconstriction and inhibits the release of pro-inflammatory neuropeptides associated with migraine.
Its selective serotonergic activity makes Frovatriptan Succinate an important API for development of oral antimigraine formulations.
Frovatriptan Succinate is used as the active ingredient in pharmaceutical products for the acute treatment of migraine attacks with or without aura in adults.
The marketed tablet strength commonly contains 3.91 mg of Frovatriptan Succinate, equivalent to 2.5 mg of frovatriptan base.
The API is therefore relevant to:
Frovatriptan Succinate has a current USP-NF monograph proposal based on validated analytical methods. The USP proposal specifically addresses assay, organic impurities, D-camphor sulfonic acid, frovatriptan enantiomer and related quality attributes. USP also lists reference standards for Frovatriptan Succinate, Frovatriptan Racemate and Frovatriptan Related Compound A.
This makes stereochemical purity particularly important because Frovatriptan is supplied as the defined R-(+) enantiomer.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |