Levomilnacipran is the 1S,2R-enantiomer of milnacipran and belongs to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) class. It is primarily used for the treatment of major depressive disorder (MDD) in adults. The pharmaceutical product is formulated as levomilnacipran hydrochloride.
Levomilnacipran hydrochloride acts by inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE) at their respective transporters, increasing their availability in the central nervous system. FDA pharmacology information indicates that levomilnacipran is approximately two-fold more potent for norepinephrine reuptake inhibition than serotonin reuptake inhibition.
Levomilnacipran hydrochloride is a specialized antidepressant pharmaceutical API requiring controlled stereochemical synthesis, purification and analytical characterization.
Key quality attributes include identity, assay, related substances, stereochemical purity, water content, residual solvents and elemental impurities.
CAS Number: 175131-60-9
Molecular Formula: C15H23ClN2O
Molecular Weight: 282.81 g/mol
Chemical Name: (1S,2R)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride
Active Moiety: Levomilnacipran
Drug Class: Antidepressant
Pharmacological Class: SNRI
Therapeutic Class: Antidepressant
Therapeutic Area: Psychiatry / CNS
Levomilnacipran inhibits the reuptake of serotonin and norepinephrine by inhibiting their transporters. This increases serotonergic and noradrenergic neurotransmission in the central nervous system.
Levomilnacipran is primarily used for:
Levomilnacipran is the 1S,2R enantiomer of milnacipran. Therefore, control of stereochemical purity is an important quality attribute of the API.
Levomilnacipran hydrochloride is described as a white to off-white powder. Regulatory product information describes it as very soluble in water and 0.1 M hydrochloric acid and freely soluble in ethanol.
A controlled API manufacturing process may include:
Typical Levomilnacipran hydrochloride API testing may include:
Store Levomilnacipran hydrochloride in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage conditions should be established from validated stability data.
Levomilnacipran is relevant to research involving:
| 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 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |