Mirogabalin Besylate is the besylate salt of mirogabalin, a gabapentinoid pharmaceutical compound that selectively binds to the α2δ subunit of voltage-gated calcium channels. It is used as an active pharmaceutical ingredient in the development and manufacture of oral pharmaceutical formulations for neuropathic pain.
Mirogabalin Besylate has CAS Number 1138245-21-2, molecular formula C18H25NO5S, and molecular weight 367.5 g/mol. The active moiety, mirogabalin, has CAS Number 1138245-13-2 and molecular weight 209.28 g/mol.
Mirogabalin Besylate is a specialized neuropathic pain pharmaceutical API used in the development of oral dosage forms. Its quality profile includes control of identity, assay, related substances, water content, residual solvents and other applicable pharmaceutical quality attributes.
CAS Number: 1138245-21-2
Molecular Formula: C18H25NO5S
Molecular Weight: 367.5 g/mol
Active Moiety: Mirogabalin
Active Moiety Formula: C12H19NO2
Active Moiety Molecular Weight: 209.28 g/mol
Drug Class: Gabapentinoid
Therapeutic Class: Neuropathic Pain Agent
Therapeutic Area: Neurology / Pain Management
Molecule Type: Synthetic Small Molecule
PubChem CID: 81689826
FDA UNII: 01F4FRP8YL
ChEMBL ID: CHEMBL3545257
Mirogabalin selectively binds to the α2δ subunit of voltage-gated calcium channels in the nervous system. This interaction reduces calcium-dependent neurotransmitter release and helps modulate abnormal neuronal signaling associated with neuropathic pain.
Its mechanism is related to the gabapentinoid class, although mirogabalin has a distinct binding and dissociation profile at the α2δ subunit.
Mirogabalin Besylate API is used in pharmaceutical development for:
Mirogabalin has been studied and used in relation to diabetic peripheral neuropathic pain and other neuropathic pain conditions.
Mirogabalin is particularly relevant to pharmaceutical development involving neuropathic pain, where abnormal neuronal signaling contributes to persistent pain sensations.
By modulating α2δ-containing voltage-gated calcium channels, mirogabalin can reduce excitatory neurotransmission involved in pain signaling.
Mirogabalin Besylate is a chemically defined crystalline pharmaceutical salt consisting of mirogabalin and benzenesulfonic acid in a 1:1 relationship. Its exact physical characteristics, including appearance, particle size and solid-state properties, should be controlled according to the applicable API specification.
A controlled Mirogabalin Besylate API manufacturing process may involve:
Typical Mirogabalin Besylate API testing may include:
Store Mirogabalin Besylate API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage conditions should follow validated stability data and the applicable manufacturer's specification.
Mirogabalin Besylate is relevant to research involving:
Mirogabalin Besylate is a gabapentinoid pharmaceutical API with CAS Number 1138245-21-2, molecular formula C18H25NO5S, and molecular weight 367.5 g/mol. It is the besylate salt of mirogabalin and acts through selective binding to the α2δ subunit of voltage-gated calcium channels.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| 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 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |